The ability to predict how drugs will act in patients has been heavily dependent on testing in animal or human trials. But now, biosimulation—the use of computer-aided models to simulate complex biological systems—is a well-established part of drug development, and rapidly growing demand for biosimulation means that we need more experts. Clinicians and scientists are needed who can run and interpret these models and position them strategically to accelerate drug development, reduce costs, and increase confidence in clinical program decision-making. How do we ramp-up talent to meet this growing need? The answer may lie in Africa.

Devoting greater resources in quantitative pharmacology training and conducting clinical trials in low- and middle-income (LMIC) countries in Africa would greatly complement efforts elsewhere and advance innovative biosimulation applications across broad therapeutic areas. Major efforts to strengthen science systems in LMICs, including collaborations focused on capacity-building with local research institutions and global stakeholders, has provided a baseline of motivated scientists trained in the fundamental skills who should be enlisted to help.

Additionally, there is a special opportunity for innovation in Africa. Drug development science, regulatory frameworks, and infrastructure are being built with little in the way of a legacy system, meaning Africa doesn’t need to dismantle entrenched ways of operating to bring modern methods into play.

Building pharmacometrics capacity in Africa will also fight brain drain, enabling job creation for African scientists. It could also have the effect of increasing much-needed representation of African patients in clinical research, thereby more efficiently advancing new, safer drugs while accelerating access to medicines.

This last point is critical. African patients currently receive therapies that were not specifically studied in them during clinical drug development and may not work as well as they could. Currently, fewer than 2% of clinical trials are conducted in Africa, but the continent displays an incredible amount of genetic variance. It is essential we capture that diversity to develop drugs that benefit patients in Africa and elsewhere.

Biosimulation can optimize safe and effective dose and treatment duration in different patient types. The pharmaceutical industry has a poor track record of getting dosing right at product approval, with about 80% of drugs having a reduction in dose within two to six-and-a-half years after approval. For adults, typically doses are too high because the dose concentration- response relationship is poorly studied during development. In pediatrics, the opposite is often the case, with doses often set too low.

Given these challenges, opportunities, and advantages, we need to tap into Africa’s educational and research resources and change attitudes about what’s possible on the continent. Current efforts to train the next generation of pharmacometricians and clinical pharmacology experts in Africa, such as Pharmacometrics Africa, WCoP, and PAGE, are attracting a large number of promising students. South-North partnerships, in which African and Western researchers collaborate to address clinical pharmacology challenges, are growing in importance and participation. These programs need investment and ramping-up.

Many people with unmet medical needs have been waiting too long for effective medicines and therapies. Investment in biosimulation is the path forward to accelerating safer, more targeted treatments and establishing more accurate dosing. It’s the right time to do it, so what are we waiting for?

Articles

A Closing Thought

The answers to meeting biosimulation's growing demand for talent may lie in Africa.

Africa is Biosimulation’s Next Frontier

Contract research organizations (CROs) have undergone significant changes in recent years, and even more changes are on the horizon. Some of the new and established trends in CROs are the result of technological advances, while others have arisen in response to market pressures or the COVID-19 pandemic. Experts say that spending on research and development has continued to grow over the last 15 years, even as the pandemic has caused biotech stocks to slump. However, CROs continue to face a variety of challenges, from competitive pressure to commoditization to evolving patient engagement models. Market stratification is placing pressure on smaller CROs to niche down or subcontract as larger organizations capture more of the market. As CROs navigate a post-pandemic future, there will be opportunities to implement lessons learned from COVID-19 and adopt emerging technologies that can improve data management, mitigate staffing shortages, or facilitate better patient monitoring and engagement.

The CRO market is in a state of flux, and navigating the changes in this industry will require improvisation and good planning. Here are some of the recent trends and emerging challenges for CROs.

The CRO space has seen a flurry of merger and acquisition activity in recent years. 2016 saw the merger of IMS Health with Quintiles, resulting in the birth of IQVIA. In February 2021, ICON entered into an agreement to acquire PRA Health Sciences. In December 2021, instrument and software supplier Thermo Fisher Scientific finalized a deal to buy CRO PPD.

While these deals have helped the industry’s largest players scale up services, they’re also putting pressure on smaller CROs.

Ken Getz, MBA, is director and research professor at the Tufts Center for the 

Study of Drug Development at Tufts University in Boston, MA. Getz says that these and other deals have enabled large CROs to consolidate expertise and resources.

“In a commoditized service area, scale is important, because it gives you a depth of business development and sales coverage in the market,” Getz explains. “It becomes harder for niche players to function, because without scale, they can’t match the price points and the muscle that larger companies can throw into every project. Some of the smaller CROs are getting squeezed out, while others are becoming subcontractors to larger CROs.”

Getz says that some small CROs may be able to resist this competitive pressure, provided they can specialize in a well-differentiated niche service like a specific type of biostatistics. However, niching down also puts smaller CROs farther away from the end client; these specialized CROs, Getz says, would be selling themselves as subcontractors to the industry’s Goliaths. Still, there may be a middle path forward for small- and mid-sized full-service CROs.

“Some of these smaller CROs will argue that they want to offer outsourcing that’s provided by a vendor similar in size to the client they’re serving,” Getz says. “That’s called right-sizing. Historically, right-sizing has been a successful strategy, but only with select companies—and it’s hard to predict who those companies will be.”

John Kreger, an equity research analyst with William Blair in Chicago, IL, says the pharma industry’s source of innovation has aggressively shifted from large pharmaceutical companies to small biotech startups. This change is prompting CROs to rethink their client engagement model to better target young, aggressively-managed startups. The next two years, he says, will see the industry embracing more innovations.

“The CROs will either be leading the effort to innovate, or they’ll be dragged along by their clients,” Kreger says. “A tangible example would be decentralized trials (DCTs). The old model of a clinical trial had the patient come to the doctor’s office once a month for two or three years. But now, with technology like Zoom and wearables, we can do patient visits from home.”

Kreger says tech-enabled CROs are growing, and they’re more broadly deploying technologies that were battle-tested during the COVID-19 pandemic.

Emerging new technologies could reshape clinical trials over the long term. Kreger says that technology adoption will become more ubiquitous over time; while CROs are only just now starting to look at novel technologies like artificial intelligence (AI) and machine learning, Kreger says this decade will see CROs continue to incorporate more of these technologies. As technological adoption grows, CROs will become less dependent on labor.

“Within artificial intelligence, there’s a field called biosimulation that involves running trials on a computer before running them in the real world,” Kreger explains. “I think technology will make trials and CROs more efficient. But this will increasingly be a biotech landscape. The notion of virtual pharma companies, which was a term thrown around loosely before, is becoming more and more real. You don’t need to be Merck to do this; you can be a small innovator and have outsourcing partners for each functional step.”

Kreger hypothesizes that as technology grows, the CRO model may change from a labor-driven model to a technology-driven one. If this were to occur, CRO operations would rely less on people and more on software. The competitive differentiator between CROs, then, wouldn’t be who has the best people, but rather, whose technology can best capture, sort, and utilize data.

Pandemic, worker shortage demand flexibility

The COVID-19 pandemic and a shortage of skilled workers have put pressure on CROs to change the way they conduct studies, and new technology is already making research more flexible. Eric Coldwell, managing director, equity research at R.W. Baird in Chicago, says that while other technologies like machine learning and AI are growing, DCTs are the single-most important trend in the CRO space today. AI and advanced data analytics may offer future innovations, but Coldwell says that DCT technology is solving a current problem.

“The most important topic of 2022 is DCTs, full stop,” Coldwell says. “If you can’t do research at a traditional site, you have to be able to do it somewhere else. What’s really interesting is that different CROs have different approaches to DCT. IQVIA claims it can do just about everything internally with its proprietary technology. Covance has traditionally worked with outside vendors, but they bought snapIoT in 2020. But then you have other companies that would rather partner with channel-agnostic technology leaders, or just be flexible and work with everyone.”

Coldwell cites the examples of CROs PPD and Syneos. Both organizations have partnership agreements with Science 37, a clinical research firm specializing in DCTs. Syneos also has a deep relationship with Medidata. Coldwell says most CROs will forge partnership agreements with DCT software developers, but three or four of the world’s largest CROs are building DCT technology in-house. These technology solutions, Coldwell says, are part of a larger trend that aims to increase the flexibility of clinical trials.

“I don’t think you can plan for COVID-19 interruptions, other than to be as flexible as possible with your approach to a trial,” Coldwell says. “We’re two years into the pandemic now. We’ve found ways to keep important trials going. Trials went from 90% closed at the start of the pandemic to 80% open today, but the reality is that 20% of study sites have always done 80% of the world’s work. We can survive with 80% of study sites open. But the big change has been this incredible growth in tools that allow a patient to visit a study site less frequently.”

Coldwell says governments and review boards have been very flexible with new technology and methodology solutions that enable fewer in-person study visits. The message from the review boards is that researchers should do what makes the most sense to keep a trial running—especially when patient welfare is at stake.

“If you have a patient who will be severely harmed if they’re denied access to an investigational drug, then you need to change the protocol,” Coldwell says. “The review boards have said, ‘don’t ask for permission, tell us what you did and then ask for forgiveness.’”

While technology has enabled CROs to conduct hybrid clinical trials involving online and in-person components, these trials come with their own challenges. Despite offering the advantage of fewer study visits and easier patient access, Getz says hybrid trials are demanding and difficult to run because they require CROs to juggle multiple different patient preferences and execution models simultaneously.

“Hybrid clinical trials aren’t making research easier for anyone,” Getz says. “A hybrid trial requires a more agile mindset, where you can adapt quickly and prepare to manage multiple executional models that you deploy at the same time. Sponsors and CROs are struggling with it.”

Getz says that while CROs have been trying to move clients away from traditional methods and toward emerging tools, these efforts have historically resulted in significant pushback. Sponsors have typically expected that CROs will fall in line with the sponsor’s own standard operating procedures. While some CROs have forged deep enough relationships with clients to gain a certain degree of latitude, Getz says that the CRO is still required to follow the sponsor’s procedures and operational requirements in many cases. This trend has continued despite hard evidence demonstrating that more flexibility from sponsors would create better results.

“We’ve gathered a lot of data at the Tufts Center that consistently shows that CROs are faster and more efficient than comparable studies managed by sponsors’ own internal teams,” Getz says. “We’ve been sharing those findings for decades, and it doesn’t seem to have influenced sponsor preferences for when and when not to outsource. The general position that most pharma companies take is that they need to provide a level of oversight where they limit the CRO’s ability to take latitude, to do things that are novel and different.”

Supply chain disruptions prompt anticipatory planning

The COVID supply chain crunch has affected nearly every sector. In June 2021, the White House published a report explaining the various factors affecting supply chains, from labor shortages to low inventory and beyond. In September 2021, McKinsey & Company noted that the pharmaceutical industry is vulnerable to region-specific supply chain interruptions like natural disasters. Disruptions are increasingly common and increasingly global, and high inventory alone is insufficient to guard against supply chain shocks.

Kreger says that CROs are hired to solve problems and keep trials on track. While all trials come with challenges, and while the pandemic has meant nearly every clinical trial has had some kind of crisis, Kreger says that solving problems is—or ought to be—the core skill of CROs.

Getz says that managing supply chain disruptions involves anticipatory planning, and several of the larger CROs are already quite effective at anticipating and resolving shortages. However, smaller CROs are more likely to struggle with these issues:

“The larger CROs have the resources to stockpile supplies or accommodate for when things get pinched down the road. The smaller CROs don’t have the resources or the infrastructure to monitor supply chains and mitigate shortages.”

Despite challenges such as controlling sponsors, a labor shortage, and market consolidation, the CRO industry will continue to be buoyed by growing demand for outsourced R&D services. Coldwell says that the main factors driving CRO performance over time have involved Big Pharma outsourcing more of their work, new biotech startups gaining financing, and regulators asking for more data and imposing more protocol requirements. He points to several other economic drivers that are also contributing to the growing need for CROs, including a more crowded pharmaceutical marketplace and a push by pharma companies to find better competitive differentiators.

“I’ve covered CROs for 27 years, and I don’t think we’ve ever seen a year where outsourcing didn’t either hold ground or gain ground in terms of market penetration,” Coldwell says. “There was a mass acceleration of outsourcing due to COVID-19, and I don’t see pharma companies bringing work back in-house. I also don’t see regulators asking for less data. What I don’t know, and where there is some debate, is what will be the ultimate impact of this rapid transition toward more fully decentralized trials.”

Coldwell expects that over time, as CROs become more effective at running DCTs, those studies will become faster and more efficient. While this shift would mean less revenue from an individual trial, Coldwell says it would also mean fewer delays, fewer change orders, and less clean-up work. As DCTs become faster and less expensive to run, he says, pharmaceutical companies may spend more money on DCTs to get more drugs to market faster.

“The debate isn’t whether there will be a lot of activity,” Coldwell explains. “There will be. The real debate in five or 10 years is whether decentralized trials will be successful enough and rolled out broadly enough to increase revenue.”

While the jury is still out on DCT revenue, past investments in mRNA, antibody therapies, autoimmune products, vaccines, oncology, and various other fields have already created tremendous demand for outsourced services. Coldwell says this increase in demand is reflected in the CRO industry’s revenue growth numbers.

“The publicly-traded CROs are looking at a 2021 revenue growth that’s close to 30%,” he notes. “The aggregated year-over-year growth of those companies is going to be in the mid-to-high 20s, which is pretty amazing. Before the pandemic, a typical growth expectation was about 6% to 8%. We’re seeing growth rates in 2022 that are beyond what was expected in 2018.”

The CRO industry is undergoing rapid growth and significant changes. While growing investment in pharmaceutical R&D is creating more opportunities for CROs, smaller players are facing competitive pressure from larger companies that have undergone recent mergers. Supply chain disruptions and labor shortages are contributing to a more challenging environment, but analysts say that CROs have the tools and creativity to solve these problems—if sponsors will accept the need for innovation. Still, the emergence of DCTs and advanced technologies are giving CROs new tools to meet demand.

In the near term, the future of the CRO industry will see companies learning lessons from COVID and implementing more technology-driven solutions. By the end of this decade, analysts say CROs will invest in AI-powered biosimulation, consolidate clinical and commercial divisions, and ramp up hybrid trials. While there will be pressure to differentiate or niche down, and to ensure services are competitively priced, a smaller slice of a bigger pie is still more pie.

Feature Articles

How CROs have adapted to recent challenges—and how they’ll continue 
to evolve in the future.

CRO Update: Where are Contract Research Organizations Headed?

The pharmaceutical industry is a stellar industry that has contributed greatly to the health of individuals as well as to the public health. Just look at the rapidity that multiple COVID-19 vaccines and antivirals have recently reached the market, and more to come. The industry has one of the smartest workforce and most come to work with passion in their bones, whether it be in their first job or those positions that followed. Thus, when all players cooperatively work together as a team with common goals, it is a win-win for society at large.

However, there are times during the development and post-marketing phases when drug and device companies identify a need to contract services when there are gaps in internal resources to fulfill milestones or when a decision is made to outsource key services rather than build an internal team. Today, the companies that are outsourced to are called contract research organizations (CROs), an industry with a rich history. One of the early CROs was Charles River Laboratories. According to its website, “In 1947, a young veterinarian purchased one thousand rat cages from a Virginia farm and set up a one-man laboratory in Boston, overlooking the Charles River. In an effort to fulfill the regional need for laboratory animal models, he bred, fed, and cared for the animals and personally delivered them to local researchers.” The rest is history.

In terms of clinical research, according to the IQVIA website, in 1974, Dennis Gillings the founder of Quintiles, signed his first contract to provide statistical and data management consulting for pharmaceutical clients. Then, in 1982, Quintiles, Inc. was incorporated in North Carolina. Again, the rest is history.

Currently, CROs provide services in the areas of 1) Good clinical practices (GCP), including protocol writing, site monitoring, statistical analyses, and medical writing; 2) Regulatory affairs, including interactions with regulators and the preparation and submission of electronic common technical documents (eCTD); 3) Good manufacturing practices (GMP), including the synthesis and manufacturing of drugs and biologics, as well as the development and manufacturing of devices and diagnostics; and 4) Good laboratory practices (GLP), including pharmacology studies in animal models of disease and toxicology studies in established animal study designs.

While CROs must run efficient and profitable businesses, there must be a balance with the three major stakeholders in all businesses, including customers, employees, and investors. The reason is that to be successful, CROs must retain long-term customer relationships, develop new customers on an ongoing basis, as well employ and retain highly experienced professionals. The reason is that without satisfied customers and satisfied employees, the investors will not get their expected return on investment (ROI). Likewise, if a CRO does not appreciate and understand that some new customers, or even existing ones, may require special treatments from time to time, including a discount here and there, some big clients may become small clients, and the opportunity to grow together with smaller startup companies could disappear.

With turnover in the pharmaceutical industry the way it is, it’s the CROs that often have expertise and experience in the medical indication under investigation. In other words, it is not uncommon for a CRO to provide scientific, clinical, and business continuity for pharmaceutical company sponsors. Thus, to maximize the CRO’s contribution to the overall development programs, the CRO should become an active member of the team. This is especially true when working with small-to-mid-size companies that look forward to listening to inputs and ideas from their CRO partner.

Hence, if a CRO can brag, as some do already, about 1) the number of regulatory interactions and approvals they have under their belt; 2) how they accelerate time to database lock; 3) the number of ongoing COVID-19 studies they are managing; and 4) the number of rare disease accomplishments etc., they will be very attractive to new and existing customers. 

News

Brief history lesson sets stage for current state of CROs.

What is a CRO?

Several years ago, the Board of Directors of the Association of Clinical Research Organizations (ACRO) decided to expand the boundaries of membership to welcome not only CROs but technology companies as well. This recognition that the software and platforms provided by technology companies are increasingly integral to the design, execution, and analysis of clinical trials reinforced the association’s long commitment to innovation in clinical development, and today ACRO’s membership is roughly half CROs and half technology companies. The mission of ACRO—to advocate for a positive and consistent regulatory and business environment in which companies that perform a wide range of clinical development activities can operate worldwide—did not change. But our voice became larger and more diverse.

In supporting clinical development projects from beginning to end, CROs and technology providers have a unique vantage point, interacting with all the stakeholders in the enterprise: sponsors, investigators, institutional review boards (IRBs) and ethics committees, research sites, research participants, and regulators.

This unique perspective on the research environment affords opportunities for data collection, and in 2020 and 2021 ACRO undertook landscape 

 of risk-based monitoring/risk-based quality management (RBM/RBQM) implementation and a preliminary evaluation of the deployment of remote and other tools in decentralized trials (DCTs) across some 6,000 clinical trials annually. Clearly, RBQM and DCTs are hot topics for everyone in the industry—and, importantly, the ACRO landscape surveys go beyond stakeholder opinions or perceptions to gather data on actual adoption at the individual trial level.

We think that is an important contribution that ACRO can make, and aim to continue yearly assessments of RBQM and DCTs and other emerging approaches to improving the conduct of clinical trials.

Beyond gathering data to characterize the current landscape, CROs and technology companies invest heavily in innovation and thought leadership, and ACRO harnesses collaboration across member companies to produce knowledge and tools that can benefit all stakeholders. For example, our DCT 

 provides a detailed analysis of design and execution considerations in undertaking a DCT, as well as a risk-assessment tool and maps that illustrate how data is gathered, transmitted, accessed, and protected in DCTs, an important consideration for regulators, patients, and others.

Another topic on which the CROs and technology companies will lead in the future is the use of real-world data/real-world evidence (RWD/RWE), which will not only provide more fulsome data for drug development, but ultimately could help to begin bridging the gap between clinical research and clinical care.

The COVID-19 pandemic very much highlighted the need for our entire industry to improve diversity and inclusion (D&I) in clinical research, and ACRO member companies are addressing D&I issues on every level, from patient and workforce recruitment to engaging with regulators and legislators on the development of policies that will support and incentivize a fairer and more equitable research environment.

COVID also proved the enormous adaptability and resilience of all the stakeholders in the clinical research enterprise; overall, CROs and technology companies, sponsors, sites, patients, IRBs, and regulators rose to meet the extraordinary challenges of a worldwide pandemic. ACRO and its member companies are determined to take advantage of the “lessons learned” over the last two years—and we look forward to a bright future for drug development.

Industry must take advantage of "lessons learned."

CROs Rise to COVID Pandemic Challenges

CVS is one of the most recognizable brands across the world. However, its work in clinical trials sometimes goes by the wayside. In this interview, Tony Clapsis, SVP, Clinical Trials Services, CVS, discusses recent advancements in the clinical trials space by CVS and how the pharmacy giant will attempt to reach more patients and healthcare providers (HCPs) than ever.

: CVS has been conducting clinical trials for about 15 years but announced last May a dedicated Clinical Trials Services business. What was the impetus for forming the business now?

The new business aims to harness CVS Health’s ability to reach more people and improve the health of communities across America through our local presence, digital channels, and approximately 300,000 dedicated colleagues—including more than 40,000 physicians, pharmacists, nurses, and nurse practitioners. Despite the important role clinical trials play in evaluating the safety and efficacy of investigational new drugs and devices, less than 4% of the US population participates in clinical studies. In addition, 80% of studies don’t meet participant enrollment deadlines, and an average of 30% of participants drop out before a study is completed.

We are helping to overcome the obstacles that result in these numbers by bringing to bear the considerable resources of CVS Health and our innovative approaches and experience to address the need to drive greater access to clinical trials across the communities we serve. About 80% of the US population and more than 40% of US vulnerable populations, as defined by an SVI (social vulnerability index) score of .5 or greater, lives within a five-mile radius of a CVS store.

ACT: Will every CVS location have clinical trials patient access?

 Our Trial Ready HealthHUB network is expanding and scaling rapidly. This expansion is done strategically based on several factors, including population, therapeutic area needs, demographics, and more. We currently have 10 sites in four states equipped to deliver clinical trials and are continuing to increase this number throughout this year and beyond.

ACT: CVS Clinical Trials Services recently announced a collaboration with Medable to use its clinical trial software platform. Is this your chosen technology for clinical trial data collection or will there be others?

Medable is the preferred technology solution for decentralized clinical trial (DCT) services. CVS Health works with many other companies to support clinical trials.

CVS Health and Medable are both committed to expanding engagement within clinical trials. Our collaboration, utilized in the appropriate settings, will help us work toward this goal. We see this as a great opportunity for two innovative companies with compatible solutions to drive innovation and results in this space effectively and at scale. Combining Medable’s software platform with CVS Health’s community reach and experienced MinuteClinic providers, we improve participant engagement, retention, and site data capture.

ACT: Clinical trials and patient healthcare are two separate areas in regard to regulations, data, and ethical intent; healthcare to treat patients and clinical trials to study the effects of a drug in patients. How will these two areas be managed successfully in the walls of a pharmacy or health clinic?

At CVS Health, standard of care and clinical trials are managed in accordance with applicable industry and regulatory requirements to ensure the safety and privacy of the patients and research subjects. The clinical trial teams handling studies are trained in accordance with applicable regulatory standards, including FDA regulations relating to good clinical practice (GCP) governing human subject protection and the conduct of clinical trials, and in accordance with the appropriate institutional review board (IRB) evaluation.

The clinical teams are trained to know when to apply standard of care operating procedures and processes vs. clinical study protocols and GCP protections to ensure that we are adhering to FDA regulations governing human subject protection.

Tony Clapsis, SVP, Clinical Trials Services, CVS, discusses recent advancements in the clinical trials space by CVS.

Utilizing Outreach and Communication 

One of the most influential organizations of professionals in the world of clinical trials has distilled the current European regulatory scene into a clear choice for the authorities: update pharmaceutical rules or abandon all hope of retaining global influence in medicines innovation. In its contribution to the current debate on the EU's ongoing review of its pharmaceutical legislation, the Association of Clinical Research Organizations (ACRO) pulls no punches.

It says, bluntly, that inconsistency of the EU makes approval and initiation of new clinical trials too slow. The consequence is that EU countries are often in the second or third rank when a clinical trial is initiated globally: so innovation in the EU is delayed, and patients suffer slower access to trials of novel treatments and ultimately delayed access to innovative products. ACRO highlights what it sees as areas of inefficiency and administrative burden, and warns starkly: "Research and development in the EU is losing ground to competitors such as China and the USA, and the EU is in danger of losing its leadership role in medical innovation."

ACRO's opinion can hardly be lightly dismissed: it represents the world's major clinical research and technology organizations, with more than 150,000 employees, including over 60,000 in Europe, and research activities in 114 countries. It has taken advantage of the EU invitation to indicate selected priorities in the rewrite of the pharma rules—which is due to appear as a firm proposal from EU officials before the end of 2022. And there is hardly a single aspect of the current rules that escapes a scathing assessment by ACRO, ranging from distinct national, local, and regional procedures for regulatory and ethical approval to a failure by regulators to keep up to date with the pace of science and technology.

The ACRO assessment is uncompromising. The EU must simplify its legislation and make its regulation attractive, by cutting regulatory approval times and costs, introducing flexibility and adaptability to innovative pathways in medicines development and evidence generation. A new framework must cater for genomics, for personalized medicine, for data analytics, and for digital tools, and must provide tailored incentives for innovation. Novel flexibilities such as the rolling reviews introduced for COVID-19 treatments "should become the standard process rather than an exception." And EU guidance should make provision for remote source data review.

Nor is ACRO reassured by the EU's extravagant claims that the new clinical trials regulation and information system herald a brave new world. This could be "an opportunity to improve efficiency and streamline overall regulatory processes," ACRO concedes cautiously. If it meets the rhetoric about “file once, use often” for marketing authorization evaluation without the need for resubmission of reports/data by applicants, it could help to reduce the overall timeline for evaluation of the marketing authorization application, ACRO hypothesizes. But only if it is "effectively implemented." And the ACRO submission does not express confidence that this will occur evenly enough to make a real difference. "It is too early to know to what extent the application of [the new CT regulation] will improve the situation and streamline regulatory and ethics committee approvals for pan-EU clinical trials," it observes. It is not optimistic: even with the new regulation, the assessment will take eight to 12 weeks from submission to approval of the application, it says, adding:"This compares with a typical period of four weeks in the USA."

Consequently, "until the EU has in place a process that provides a rigorous regulatory and ethical review with similar timelines, it will be difficult for the region to be competitive for clinical research, especially for early phase clinical trials," says ACRO. And persistent inflexibility around submission and processing of substantial modifications will likely lead to delays in implementation of changes required to clinical trials, further reducing the attractiveness of the EU, it adds.

On top of that, ACRO highlights limitations in the clinical trial information system now coming into force, notably in handling platform trials and other novel designs and in taking account of increased digitalization of clinical research and the trend toward submission of data rather than of reports. Meanwhile, it says, data protection implementation varies greatly across the member states, and diverse national approaches limit electronic informed consent and electronic signatures.

All this against a background of variability "caused by too many sites, and the inability of patients to participate because they do not fall within the small catchment area of a particular site." ACRO is calling for centralized patient records that would allow physicians and clinical investigators to offer patients not directly under their care the opportunity to participate in an appropriate clinical trial. But Europe is plagued by "unnecessary bureaucratic delays" that hamper patient access to trials. Among its most radical suggestions, the ACRO submission attacks the traditional distinction between clinical care and clinical research. "This outdated perspective fails to recognize the interconnectedness of clinical care and clinical research, thereby harming the competitiveness of the EU in clinical research," it says.

ACRO urges new rules that would oblige efforts at integration, such as "presenting clinical trials as a care option" and encouraging the “pre-consent” of individual patients about their willingness to be considered for clinical research projects. Branding this "a major omission," ACRO says the EU focus on ethical considerations and patient safety "does not reflect modern attitudes and approaches to patient centricity," it says, citing a chronic fragmentation of clinical care and clinical research. ACRO recommends adoption of “patient centricity by design,” with greater patient involvement and increased reliance on patient-reported outcomes in regulatory decision-making.

Overall, this is a damning assessment by professionals who spend their working lives grappling with the realities of designing and running clinical trials in what it sees as an obsolete EU framework. Among the 500 or so contributions the EU has received as it creates its new rules, ACRO's is conspicuous for its intense focus on clinical trials—although some of the points it makes are echoed in many of the submissions from the pharmaceutical industry. The outcome in terms of legislation will not, however, be conditioned uniquely by considerations of trial efficiency. The political context is, as ever, determinant in EU affairs, and that will respond not only to the aspirations of clinical trial professionals, but also to the views of patient and consumer groups that have repeatedly made clear their demands for tighter controls on all aspects of drug development, and their suspicion that calls for efficiency are merely a cloak for the headlong pursuit of deregulation.

Just how the EU proposes to resolve these tensions will become clearer over the coming months as the shape of its new legislative framework emerges.

View from Brussels

Organization says either reform European drug development rules—or lose out on global competition.

 ACRO Offers Blunt Take on EU Clinical Trial Legislation Pursuits

 when Judge Marilyn Milian says, “We are going to do a little rough justice”? It means she’s about to render a decision that she thinks is fair, but not entirely based on the result of the testimonies or evidence given. And that’s what we are presenting. 

’ list of 45 CROs based on the rough estimations that we could gather.

, which reports on the current state of the CRO market. This list is a fair representation of data we found from various internet sources, suggested input from vendors and industry providers, company websites, publicly available SEC forms for public companies, as well as Dun & Bradstreet, Zoom info, Owler, and Crunchbase. We erred on the side of the greater numbers found and we did not reach out to the companies to verify. We did that based on our own staff limitations, timelines, and knowledge that next year we will be launching an online service provider directory for the industry. This is just the first iteration for the opportunity to grow that list and database into a comprehensive industry resource.

While we do that, we encourage interested parties (i.e., those that were not intentionally left off of this list and who very likely will not be happy about it) to email me directly, at lhenderson@mjhlifesciences.com, so you can be filed for further outreach when the directory goes into production.

For more insights into the state of the CRO industry, please see commentary on page 10 from ACRO’s Executive Director Doug Peddicord, PhD. Here he states that technology providers are now members of the CRO association because of their necessary integrations and support to the industry.

Which brings up an interesting point. What is the division between a tech and/or service provider and a CRO? They all provide services, where do we draw the lines? In our list, we have included only companies that provide trial, site or data management, biostats, etc. Tech and service providers remain recruitment companies, consultants, technology integration, wearables, patient outcomes measurements, AI, analytics, etc.

As we head into developing our directory, please join us on the journey to redefine—and newly define—the nomenclature of our industry based on tech advancements and the numerous new vendors in our ecosystem. 

 is Editor-in-Chief of Applied Clinical Trials. She can be reached at 

From the Editor

Applied Clinical Trials introduces its first ever list of CROs.

A List of CROs with Rough Justice Applied

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The heightened political debate that delayed his Senate confirmation, plus continued challenges created by the COVID-19 pandemic, ensure that Dr. Robert Califf’s tenure leading FDA will be much more contentious than his previous stint. His Senate confirmation process was punctuated by sharp queries from both sides of the aisle about access to COVID tests and therapies, agency policies for speeding new drugs to market, and FDA’s role in facilitating access to both long-acting opioids and to medicine to induce abortions, as the politicians sought to make points with constituencies leading up to mid-term Congressional elections in November.

That partisan tone was apparent in January as the Senate Health, Education, Labor & Pensions (HELP) Committee voted to advance his nomination as FDA commissioner by a close 13 to margin.

 Final Senate approval by an historically narrow 50-46 vote came only after the White House and Califf’s supporters lobbied hard to gain sufficient support, a success that is very different from Califf’s 89-4 approval back in 2016. Four Democrats and independent Bernie Sanders opposed the nomination, citing Califf’s close ties to industry and his failure to halt access to opioids. Califf won the vote of Sen. Elizabeth Warren (D-MA) and some others by agreeing to extend ethics restrictions on his future involvement with industry.

Only six Republications voted for confirmation, led by HELP Committee ranking Republican Richard Burr of North Carolina, who championed the appointment of his fellow Carolinian as a knowledgeable scientist and experienced policymaker. Most Republicans preferred to rail against FDA’s “pro-abortion agenda,” amid the agency’s recent decision to remove curbs on prescribing and dispensing medications that induce abortion at early stages of pregnancy.

Califf’s first order of business is to support the development and approval of drugs, vaccines, and diagnostics vital to taming the ongoing coronavirus pandemic. FDA’s recent decision to delay consideration of a COVID vaccine for very young children indicates that many difficult scientific and legal issues remain on the agency’s agenda. Califf will benefit considerably from the experience and assistance of Acting Commissioner Janet Woodcock, who as agreed to remain at the agency as his principal deputy commissioner.

An immediate challenge for the commissioner is to revisit and clarify the risks and benefits of the agency’s accelerated approval (AA) programs and to ensure completion of required confirmatory trials. Califf promised such an effort to several uncertain senators concerned about FDA’s approval of and access to the Alzheimer’s drug Aduhelm and about a proposal from the Centers for Medicare and Medicare Services (CMS) to limit Aduhelm prescribing to patients participating in clinical trials. If adopted, the coverage with evidence development requirement could apply to similar Alzheimer’s treatments moving through the R&D pipeline, which has raised fears of discouraging further research in the Alzheimer’s field by patient groups and biopharmaceutical companies. The situation has fueled debate over FDA’s reliance on limited evidence in assessing new products under the AA process and the scope and timing of post-approval confirmatory studies. Meanwhile, the Department of Health and Human Services (HHS) inspector general is investigating the Aduhelm approval decision by the Center for Drug Evaluation and Research (CDER) and whether reviewers behaved properly in weighing the risks and benefits of the therapy.

Patient advocates also want FDA to increase diversity in medical product research and to advance treatments for rare diseases, improved antibiotics, and safer gene and cellular therapies. Pressure to help control the high cost of prescription drugs will continue to drive FDA support for developing complex generic drugs and biosimilars. FDA has taken action against scores of clinics and operations promoting unapproved COVID treatments, many presenting serious health risks to consumers.

Oversight of drugs and medical products is only one area presenting many hot-button issues for FDA’s leadership to track and tackle. There is pressure to clarify rules governing e-cigarettes amid concerns about flavored products luring young people into tobacco use. FDA also has to address serious health problems arising from contaminated food and seafood, including significant volumes of imported products. The safety of cosmetic products, dietary supplements, sunscreens, and other non-prescription products raise additional complex issues, many described in FDA’s annual report for 2021, which outlines these and several other high-priority regulatory programs.

Amid all these programs, probably the most consequential assignment for FDA’s leader is to win Congressional support for agency funding and resources. This year, that entails the timely approval of new user fee agreements on drugs, generic drugs, biosimilars, and medical devices as part of a larger legislative package that must be passed by Sept. 30. Califf comes to the job with valuable experience in these areas, which he will need to manage the many controversial decisions and heavy political pressures ahead.

https://www.help.senate.gov/chair/newsroom/press/help-committee-advances-fda-nominee-dr-califf-others

https://twitter.com/FDASpox/status/1493655619366264839

https://www.fda.gov/media/155422/download?utm_medium=email&utm_source=govdelivery

View from Washington

Pressurized political, COVID climates greet his return to top spot.

A Rocky Road Ahead for New FDA Chief Califf 

The acceleration of drug discovery and development has taken on even greater importance as we face a third year of the COVID-19 pandemic. The industry has responded by incorporating remote monitoring techniques and fast-tracking the use of hybrid and decentralized clinical trial (DCT) models, at a pace never seen before. To sustain the momentum on these and other innovations that support study execution, we have also seen the rise of the #NoGoingBack initiative which aims to ensure that the progress made doesn’t fade when the pandemic finally fades.*

Despite these short term achievements, it is still taking more than 20 years to reach industry-wide adoption of various technologies and innovations that could prove beneficial to clinical research operations. Interactive Voice Response Systems (IVRS) and Electronic Data Capture (EDC) solutions were introduced in the late 1980s and early 1990s but these are only now reaching wide adoption

 by sponsors and CROs. Electronic Patient Reported Outcomes (ePRO), Electronic Clinical Outcomes Assessment (eCOA), and eSource technologies, while introduced in the mid to late 1990s, have yet to achieve wide adoption.

 This pattern holds true for risk-based monitoring, digital health outcomes, and other innovative approaches and solutions. While these innovations offer great promise, their potential can’t be realized if it takes two decades or more for them to be fully embedded into the drug development process.

In a first attempt to understand the factors impacting technology adoption, a 2020 Tufts CSDD study revealed that financial and regulatory concerns topped the list.

 Lack of trust in the technology was also reported as an important factor in that study. Additionally, it also revealed that organizational culture and senior leadership’s approach presented significant challenges to the process of technology adoption.

To gain further insights into the barriers to and opportunities for accelerating innovation adoption at both the industry and company levels, the Tufts Center for the Study of Drug Development (Tufts CSDD) undertook additional research in 2021. The purpose of this research is to characterize the long term adoption experience of technologies and capabilities supporting clinical trial execution. This research takes a long term view, and since we have yet to see the permanence of the changes that are taking place during the Covid-19 pandemic, these changes were not the focus of this research.

The research comprised informational interviews and an online global survey of biopharmaceutical executives and clinical research operations personnel. The research was completed in collaboration with WCG Avoca and seventeen biopharmaceutical sponsors who formed the working group (WG) participating in the project.

This article will provide some high-level findings from the research with a focus on actionable steps that biopharmaceutical executives can take to foster and support the adoption of innovations within their companies, namely:

Instituting mandates for greater operational efficiency

Greater support, involvement and engagement by senior leadership throughout all stages of the innovation adoption process

Offering incentives and recognition—and eliminating penalties—to individuals who promote innovative behaviors, approaches, and technologies within the organization; and

Implementing better change management, planning, and communication activities early on, and throughout the process.

The Primary stages of innovation adoption

Two predominant models exist that provide context for how innovations are adopted. The first model is the Gartner Hype Cycle, developed by Fenn in 1995. The second model is known as the Innovation Diffusion Model, developed by Rogers in 1963.

The initiation stage involves identification of the need to try a different technology, process, system, or approach to optimize clinical trial execution. This is where organizations gauge the interest and start the initial planning for trying or testing out an innovation. This is followed by the evaluation phase, which typically involves pilot projects or other assessments of the potential innovation. Based on results from the evaluation phase, organizations typically go through a decision-making process to either abandon or move forward with enterprise-wide adoption of the innovation. This is finally followed by a series of communications and training activities in support of broad implementation of the innovation throughout the organization.

These models informed the development of an interview guide and global survey. Twenty interviews were conducted with various stakeholders from the working group’s member companies. The interviews provided insights into the stages and decision-making processes that sponsor organizations follow to identify and evaluate potential innovations in the clinical development process. The findings from the interviews then shaped the creation of a global survey. The survey was organized into four key stages of the innovation adoption process, namely, initiation, evaluation, adoption decision and full implementation (Figure 1).

Survey methodology and data characteristics

The survey was primarly structured according to this four-step process with questions aimed at further understanding the process of adoption for new processes, systems and/or technologies that are transformative in terms of how the industry designs, plans, executes and manages data supporting clinical trials. Specifically, respondents were asked to consider innovations that are still emerging and haven’t yet reached industry-wide adoption. Illustrative examples were provided for reference and included eSource, eConsent, Risk Based Monitoring (RBM), Digital Health Endpoints and AI capabilities.

The survey asked respondents to characterize the timeframes for going through the various stages, the functional groups involved in the process, the types of quantitative and qualitative information used to advance from one stage to the next along with key challenges and barriers associated with each stage. Broader questions related to perceptions about how companies fared in their innovation adoption approach compared to others, and about how respondents viewed their company across the innovation diffusion model—innovator to late adopter or laggard—were included. The survey also captured perceptions of how the pharmaceutical industry compared to other industries when it comes to speed of innovation. Finally, the survey focused on opportunities for accelerating the innovation adoption process.

A total of 552 responses were received from a global audience primarily representing pharmaceutical and biotechnology companies. Approximately six percent of the respondents were from CROs or other organizations; however, responses from these individuals were not included in the primary analyses. Just over half of the respondents (53.9%) worked across large sponsors with 28% working at mid-size companies and 18.1% at small biopharma.

Nearly half of responses (49.3%) were received from individuals whose company headquarters were in Europe. 38.8% and 12% of responses were received from respondents with company headquarters based in North America and Rest of World (ROW), respectively.

A variety of roles were also represented, including professionals from Clinical Operations (46%); Clinical Development (9%); Innovation Management (17%); Data Science & Data Management (10%); Information Technology (3%) and 15% from other roles. About half (51%) of respondents reported that they had some influence on the adoption decision making process, with 30% indicating they had little to no impact on the decisions. 19% of respondents indicated that they were key decision-makers when it comes to the process of pursuing, evaluating, or implementing innovations in their organizations. Finally, 14.5% of respondents were part of a centralized or dedicated innovation group whereas the majority (85.5%) worked outside of such an innovation group.

Over two-thirds (69%) of respondents indicated that the adoption process within their organization generally followed the four-step approach as outlined above (Figure 1). Where the process differed, respondents indicated that there was no formal process, or that certain steps were less defined or skipped altogether. Interestingly, some respondents from smaller companies reported having staff with experience at large companies where things were “overprocessed”, and have therefore made the decision to eliminate the process altogether. These companies intentionally decide to move straight into implementation, preferring to sort out issues along the way rather than formalizing the method and/or metrics by which they evaluate and implement an innovation.

Thus, responses reflect a broad crosssection of views and perspectives from which to learn more about how the biopharmaceutical industry approaches the innovation adoption process, what gets in the way and how organizations, and the industry more broadly, can accelerate new technologies and innovations.

The survey results revealed that within individual biopharmaceutical companies the average innovation adoption cycle for a given clinical operations innovation lasts about 6 years. The longest reported cycle lasted 10 years with the shortest lasting 1.5 years (Figure 2).

Cycle times varied by company size. Small biopharma reported the fastest cycle times and mid-size companies reported the longest (Figure 3).In general, the time to complete each stage increased across the four stages with the initiation step being the shortest and the full implementation stage taking the longest. The high coefficient of variation (CV) suggests wide variation in the length of each stage of the innovation adoption cycle.

When it comes to the impetus to pursue or explore an innovation, the results suggest that the primary factors are (1) a new or updated regulatory guidance, (2) an operating objective to improve the speed of clinical development, or (3) a mandate from senior management to pursue an innovation (Figure 4). The support and advocacy of senior leadership along with regulatory compliance and approval considerations were also big drivers of the decision to progress to the next stages. Financial considerations were among the top three drivers during the evaluation, adoption decision, and full implementation stages. The presence of change management strategies played a key role in the decision to move forward with full implementation.

When asked about barriers and challeges, study participants reported that the easiest stages to complete were the earlier stages of the process (initiation and evaluation) with the adoption decision and full implementation stages being the most challenging (Table 1).

Some interesting themes emerged in the analysis of barriers to completing or advancing to the next stages of the innovation adoption process. Key themes include:

Specifically, employee turnover and lack of cross-functional alignment are key factors that play a role across most stages. The lack of senior management involvement and support was identified as a key barrier at the evaluation and full implementation stages.

The lack of regulatory clarity and need for legal review and approval of the given innovation were reported as barriers across all stages indicating that companies like to ensure legal and regulatory acceptability prior ot moving to the next stage.

Financial constraints were noted as barriers in the three later stages, but were not reported as an issue impacting the initial pursuit of a potential innovation. Interestingly, the misalignment of incentives was also noted as a key barrier through the three later stages as well. This comes in the form of lack of rewards or recognition for exploring and advancing new ideas and the perceived risks associated with not meeting deadlines or budgets.

During the evaluation and adoption decision stages, difficulties in comparing vendors and uncertainty about the viability of a given vendor factored more heavily into the process to advance to the next stage, compared to vendor related considerations in the initiation or full implementation stages.

The absence of change management strategies and planning were identified as important challenges at the beginning and end stages of the process.

Opportunities to accelerate adoption of innovations

Many of the challenges and barriers noted by study participants are actionable.While there is recognition that greater regulatory clarity would be helpful in accelerating the process, this is often outside the direct influence of senior leadership (but something that regulatory agencies could do to facilitate more rapid adoption of new innovations). Nonetheless, respondents identified many opportunities for improvement in areas related to personnel, finances and incentives, and operations.

Senior leadership’s presence and support throughout the process

The most striking finding is that visible senior management support and promotion of an innovation throughout all stages of the process can lead to its faster adoption. Repondents echoed the signifincance of senior leadership mandates—as well as their presence and engagement at all stages—in improving the speed of innovation adoption. These perceptions align well with the correlations observed between companies with shorter timelines and the presence of senior leadership at each stage of the adoption cycle. Those companies that had senior leadership involvement at all stages also showed shorter timelines compared to those without. The mandates and support of senior leadership, coupled with the establishment of operational objectives to improve the speed of clinical development, can lead to shorter adoption cycles.

It is important to note that active, visible involvement and encouragement by senior leadership is currently a key factor in the speed of innovation adoption because the decision-making power on matters that affect innovation adoption tends to reside exclusively with this select group. An alternative approach that has been looked at, particularly within larger organizations, and which warrants further investigation is one where this decision-making power—and the accountability that follows it—is adequately distributed among teams and individuals throughout the organization.iv This approach could offer companies the ability to adapt easily, and to quickly make decisions that directly impact the speed of innovation adoption.

In a similar vein, company leadership are encouraged to continue to develop a culture of innovation within their organizations and across industry. Our research showed that nearly half of the respondents (42%) indicated either high or moderate risk to their performance review when pursuing adoption of an innovation. Thus, leaders are encouraged to build incentives for participating in the innovation adoption process into individual performance reviews.Offering incentives and recognition for the pursuit of a new approach instead of only holding individuals accountable for adherence to study timelines and budgets tends to be correlated with higher satisfaction with the innovation adoption process within biopharmaceutical companies. Providing adequate funding, resources and financial incentives to these individuals so that they can explore, pilot, and drive the adoption process can lead to quicker innovation adoption timelines. Additionally, leaders should be mindful of inadvertently penalizing individuals who develop, champion, and/or try new ideas, approaches and technologies.

Another important element for the development of a culture of innovation is the presence of a change management strategy. Study participants reported that change management strategies and communication planning play significant roles in fostering faster adoption. Waiting for the full implementation stage to think through how the organization will use, integrate, and manage a given innovation may hamper its rapid adoption.

An important outcome of this research is that substantive differences in cycle times were not identified between companies that have a dedicated innovation group compared to those that don’t. Intuitively, the presence of a dedicated innovation group would lead to faster cycle times or fewer challenges in the later stages of the process; this hypothesis was not validated here, however. Interestingly, respondents from smaller biopharma companies suggested in high proportion that innovation groups could help accelerate the adoption process. These were also the same companies that reported the presence of innovation groups in the lowest proportions compared to mid-sized and large pharma, while reporting the fastest timelines. The faster timelines observed at smaller biopharma might be explained by their greater reliance on CRO partners, the smaller scales in which they work, and their high degree of specialization in one or few therapeutic areas, among other factors. This topic warrants further investigation and is an area that we hope to explore further in future research.Based on our extensive review of examples in the literature, the stages of the innovation adoption process, and the durations and challenges, are consistent with those encountered by similar, highly regulated, research intensive industries.

The industry may be missing out on key opportunities to accelerate drug development through a lengthy and inefficient process for evaluating and adopting innovations. Cross-company collaborations, partnerships with CRO and vendor partners, and regulatory guidance and clarity can support broader industry-wide adoption of innovations.We recognize that the rapid adoption of DCT solutions during the pandemic was facilitated in part by unprecedented proactive and accommodating regulatory agency involvement

At the company level, this research found that full implementation of a new technology or process in clinical operations can be achieved in under two years. Through mandates, senior leadership involvement, cross-functional engagement, financial support, better alignment of incentives, and improved change management and planning, biopharmaceutical companies can be more proactive and intentional about the way they explore and pursue innovations.

We would like to acknowledge the study’s Working Group for their contributions to this research.

*In this research we are defining “wide-adoption’ as approximately 70% of industry having decided or being in the process of fully adoping the technology or capability.

https://www.outsourcing-pharma.com/Article/2020/10/29/NoGoingBack-mission-brings-trial-pros-together

Tufts CSDD Analysis, presented at Veeva R&D Summit, June 10 2019, Barcelona, Spain

Tufts CSDD White Paper – Adoption of Innovative Technologies within Pharmaceutical R&D, May 2020

Characterizing the long-term adoption experience of clinical technologies and capabilities—and what senior leaders can do to drive adoption within their walls.

Accelerating Innovation Adoption to Support Drug Development Operations

The pandemic has shown that there’s a lot more flexibility in clinical trial systems than what was realized in the past. It has been a catalyst in speeding the digital process, making virtual trial conduct becoming a reality. The FDA has also given the green light to shift clinical trial conduct to a virtual setting where possible to maintain patient safety with better monitoring.

 To continue the momentum, life sciences companies need to have a dependable set of global and regional external partnerships that are flexible and scalable. These partnership models (e.g., CROs and FSPs) need to fit the diverse needs of small, medium, and large companies and a variety of “future-ready” operating models that can span clinical operations and associated functions (e.g., PV, regulatory).

As the name indicates, the FSP model describes the engagement model utilized by sponsors with partner(s) to outsource either most of a function’s activities or a limited set of activities. The engagement model can be either FTE (cost of resource/hour) or unit/deliverables based (e.g., number of Case Report Forms (CRF), Tables, Listings, Figures (TLF), PV cases, and number of visits). In an environment where sponsors are challenged to manage their staffing capacity, with a broad set of skills needed in the face of dynamically changing clinical study or PV case volumes, the flexibility and scalability of the FSP model allows sponsors to manage the demand more effectively. This can allow them not only to expand the number of studies, therapeutic areas and innovative operating models, but also drive innovation and transformation in collaboration with their FSP partners and/or in a hybrid model with other CRO partners.

There was a misconception in the industry that FSP model is only a staff supplementation model, but this has been overcome by the positive experiences in leveraging them beyond just staff augmentation.

 Strategic investments by FSP vendors to advance their domain and operational expertise, leveraging of automation, six sigma approaches, digital technologies, and implementation of proprietary collaborative platforms to deliver 24x7 globally integrated services has allowed more and more sponsors to establish strategic partnership with FSP vendors.

 This has allowed the model to deliver on unit or deliverables-based engagement models (not just rate card/FTE/hour) and commit to continuous improvement, innovation, and transformation objectives of sponsors for the function being outsourced

Increased adoption of decentralized clinical trials, AI/ML platforms, and remote/centralized monitoring is allowing the FSP partnerships to be increasingly more strategic and part of the overall business and sourcing strategy. Some of these and other aspects leading to the rise of FSP outsourcing in drug development has been shared by other experts as well.

Key functions and sub-functional areas within clinical development that have been outsourced as part of FSP model are outlined below:

Biostatistics, statistical programming (BS&P), data standards, conversions (e.g., CDISC)

Based on our experience in advising clients and providing FSP/CRO services over the past 20 years, we have seen the creative bundling of some of these functions as part of the extended FSP partnership model. 

Combination of CDM, BS&P and data conversions

Extension of the CDM, BS&P and MW into a “clinical data services’ package

Combination of clinical monitoring, CDM, BS&P and medical monitoring into a “centralized monitoring team” (Potential future services)

Combination of PV and regulatory activities due to regional synergies and submission / compliance requirements (Potential future services)

To ensure that the FSP model is strategic and provide the sustainable mode of partnership, we have shared some of the best practices below that can be leveraged and further customized as needed by sponsors:

 As sponsors refine their strategic plans, TA portfolio and geographical locations for product(s) launches, they need to adapt their sourcing (insource or outsource) and outsourcing plans to include FSP model as a standalone model to complement their internally sourced trial operations and technology strategy or combine it with their CRO model in a seamless fashion. They should also define their people strategy, such as potential rebadging/rehiring of duplicative skills across the function and technology to the strategic vendor(s) and if a set of applications/platforms and tools transfer will be part of the partnership as well. 

Sponsors should collect past years’ (typically 1-3 years) core operational level metrics (e.g., Service Level Agreement (SLA), Operational Level Agreement (OLA)) in addition to their planned strategic business outcomes (based on their growth vision and benchmark data), to vendor(s) as part of the RFP process for ensuring transformational and customized engagement models to be negotiated. 

Examining best practices in using the functional service provider model 
for clinical operations, pharmacovigilance, regulatory, and other areas.

Applied Clinical Trials-03-01-2022