Vice President, Vault R&D and Quality, Veeva Systems

Jim Reilly

As life sciences and medtech companies settled into new operating models and remote ways of working over the last year, many came to realize that a return to pre-pandemic days was no longer necessary. The accomplishments and innovations of last year will pave the way for long-term changes across research and development operations in 2022.

Powered by learnings and insights from having more robust data, companies will achieve new levels of efficiency that will result in more patient-centered care. Here’s how Veeva envisions this coming together in the year ahead.

A single, centralized platform for data will be fundamental in shifting to hybrid digital trials

As clinical leaders advance from decentralized approaches to more connected digital trials, many are realizing the importance of having a strong data foundation. Patient data must be aggregated and cleaned, if it is coming from new sources such as wearables, to connect it with trial and clinical operations data. Most organizations are employing “brute force” manual methods or hiring a small army to map and clean data from digital sources.

Enabling better clinical trials requires the ability to be adaptive in design and execution so allowing more effective data management, with technologies that automate and speed processes, will be a top priority and a fundamental first step for companies moving toward true digital trials. Using data management tools that ingest, aggregate, and clean data will make it easier for clinical teams to analyze and share reliable information during study conduct.

With clean and accessible clinical data on a single platform, users benefit from real-time visibility and greater insights. As companies deploy hybrid digital trials, this data foundation will enable a seamless flow of information across functions and stakeholders to drive better collaboration, decision making, and speed.

Artificial intelligence increasingly drives efficiency, process improvements in trials

The adoption of purpose-built eTMF applications 

. The move from paper to digital has fueled positive change in the industry, enabling organizations to manage their trial master files (TMF) more actively and optimize their processes. Looking ahead, artificial intelligence (AI) in TMF will increasingly drive efficiencies and enable strategic process improvements for long-term success.

One leading clinical-stage biotechnology company adopted AI within their eTMF to help process documents quicker. They identified that site management documents were frequently duplicated during the handoff between the site start-up team and the monitor’s first on-site visit after site activation. With AI to auto-classify documents, they could process documents and increase visibility for those documents across teams more quickly—reducing the risk of duplicating them.

AI offers tangible ways to improve day-to-day operations and replace transactional activities, like document classification, with strategic activities that support long-term success. In 2022, we’ll see more stories around the successful application of AI in clinical trials, enabling greater flexibility and speed in execution.

Pharmacovigilance transformation hits high gear

R&D may have been one of the last areas in life sciences to modernize and transform its operations, but the use of new business approaches and technology have had a significant impact on operations within clinical and regulatory. Pharmacovigilance is now hitting its stride as more companies reimagine how they handle case intake and processing, in parallel with their document management needs. Safety departments are also taking a more proactive approach earlier in drug development and investigating more advanced technologies for signal detection, analysis, and management.

This year, automation and finding new ways to process data will be vital to improving patient safety and maintaining compliance. So will simplifying data management systems, their validation, and ongoing maintenance. We’ve seen more than 50 life sciences companies, from small innovators to large enterprises, 

modernize pharmacovigilance data management

As the technology modernization trend continues next year, safety departments will focus on the opportunity to manage their end-to-end pharmacovigilance processes and information more holistically, in a more efficient and compliant manner.

Diagnostics and pharma forge a better path for personalized treatment

The genomics revolution is accelerating as costs drop and disease states expand, driving increased collaboration between genomics organizations and pharmaceutical companies. With no sign of slowing, these partnerships will redefine precision medicine with new companion products (CDx) personalized for the patient and therapeutic drugs. As a result, companies will be able to better identify risk of adverse events or opportunities to adjust treatments for higher efficacy.

With a collaborative, patient-centric approach, the collection and sharing of outcomes will be critical for future advancements. This will lead to a shift toward more connected, digital landscapes that enable seamless and automated data exchange across stakeholders.

European regulatory requirements get real, driving massive change in operations

The industry has been preparing for EU MDR and IVDR for nearly five years, yet more critical work remains to ensure compliance. This is especially important as companies adapt to changing market conditions and growing global demand.

An area in need of transformation, for example, is claims management. Claims are continuing to get narrower and more defined. To adequately manage claims under regulatory changes, companies need to connect regulatory and marketing content operations processes. Regulatory teams leveraging end-to-end claims management processes can drive faster reviews and approvals, improve compliance, and gain insights into actionable data like claim usage and campaign performance.

As the clock ticks towards the full implementation of EU MDR and IVDR, the industry will continue to modernize operations to establish a stronger data foundation, improve connections across cross-functional teams, and drive real-time visibility into data and content. If companies can do this, they will be much better prepared for implementations.

With more industry changes on the horizon, a growing number of life sciences companies are reimagining their operations. The 

shift to digital and connected systems is well underway

, driving greater efficiency and speed across product development. Positive change is happening across R&D, supported by modern technologies. This will help companies keep pace with evolving market dynamics—from regulatory updates taking effect like IDMP to changing patient expectations—and accelerate the development and delivery of life-saving products to the patients that need them.

, Vice President, Vault R&D and Quality, 

, Vice President, Vault RIM and Safety, and 

, Vice President, Vault MedTech; all with Veeva Systems

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Bayer is taking decisive steps to modernize clinical operations and 

. Leading efforts to eliminate silos, streamline processes, and improve connections with Bayer’s research site partners around the world is site management team leader Emma Earl, a 2021 Veeva R&D Hero. Through her efforts, the company is developing a culture of continuous, incremental improvement, or what Japanese business strategists have long called 

Earl began her career at Bayer 22 years ago, and now heads a global team that works closely with technology vendors and manages global networks of users, applying both systems and process know-how to improve operations.

Earl also manages integrated processes across systems such as Bayer’s site-monitoring system, which accounts for 30,000 reports each year, in one of Bayer’s CTMS systems. “In a non-standardized world, getting sponsor companies to do things the same way is difficult,” she says. Earl sees this as an area where modern, unified processes can add long-term value. “Shaving even 20 seconds off a process step that is used by over 1,000 employees makes a big difference. All the little steps add up," she explains.

Although the industry is moving to digital processes, clinical trials have long been synonymous with paper. With a modern eTMF and purpose-built study startup systems in place, change management is the greatest challenge facing Earl and her team. “You can give somebody the best tool in the world, but if they persist in trying to work around it, you won't realize the efficiencies it was designed to give. Trying to get people to come along with new approaches is hard work,” she says.

New tools are intuitive and have great search capabilities, she says, but their power also presents users with different choices. “Paper may have been tedious, error-prone, and time-consuming to work with, but its associated work processes were simple, well defined, and flexible. For some first-time users, ‘decision paralysis’ can set in when they have to set boundaries around work processes,” Earl notes.

In addition, the people most affected by change aren’t always on the receiving end of its benefits—at least, not initially, Earl explains. There is a need for users to see a much bigger picture. “They have to understand that they will be entering data into a system that offers more overall transparency and visibility across functions and users, and also supports multiple purposes,” she says.

As her team moves from data repositories to active data systems, it is trying to eliminate trackers, so that data are entered directly into one system. With previous legacy systems, every team had its own study SharePoint and their own spreadsheets, resulting in two or more filing systems to maintain. Many individuals are spending one to three hours a week just to update trackers, Earl says. Old habits die hard, and some will continue to use spreadsheets, even though every data point is already entered, and updated automatically, in the new system.

“Until we can get teams to relinquish control of those trackers, some users may see the new systems as requiring more time, when they actually save time,” she says. At this point, Bayer’s first clinical trials using an advanced study startup system just completed first patient enrollment, so it is too early to have any success metrics to share yet. Earl expects to start seeing benefits once more people become accustomed to working with the new tools.

To help with change management, the team sends employees updates via newsletters and a SharePoint system, as well as through change ambassadors and specialists. “The information is there, but the bigger task is to move people to it,” she explains. “Study startup is especially complicated, particularly when the concept of trial milestones are new to all. ‘Expected documents’ was a term that many of them had never heard until last year,” says Earl.

Working with research sites: making technology 

But change management also affects users outside Bayer. With Veeva Vault SiteConnect, for example, timing implementation at research sites is a major challenge. “Site study teams are under intense pressure to start up studies as quickly as possible, and it complicates processes when you introduce new technology at this point,” Earl says. Finding the optimal timing to increase site engagement is challenging. If following study-specific outreach, then engaging sites too soon and before selection is not ideal, as it can give a false impression of successful site selection.

Nevertheless, Earl sees the use of flexible site connectors as a major improvement over traditional sponsor portals, which are complex and may require multiple integrations. Besides, some research sites simply refuse to use anything branded as a portal, while others want to use their own electronic Investigative Site Files. “Making technology the site’s choice is important,” Earl says.

Bayer is still on a learning curve with its digital technologies, but Earl expects them to aid standardization, boost efficiency, and show sponsor consistency, which is important to sites. She also sees standardization improving the speed and quality of trials, for instance, by allowing trial documents to be reused for similar studies to prevent teams from having to reinvent the wheel. Earl’s next goal is incorporating more visibility into its new business tools so that decisions become increasingly data driven.

Looking ahead, Earl and her team are working on establishing stronger connections between clinical operations and Bayer’s regulatory and pharmacovigilance operations.

“Cross-functional communications have led to some tough conversations and questions, such as ‘Where should that document live, and who does it belong to?’ but we’re able to work those issues out together, to find the best path forward, and think of the overall impact, rather than each team focusing on [maintaining] control,” she comments.

“Getting users to see the big picture is a work-in-progress,” Earl says. Day by day, her team’s efforts are establishing the foundations needed for more efficient clinical operations, as they convince more users, inside and outside the company, of the benefits and the need for change.

is the Vice President, Vault R&D at Veeva Systems

How site management team leader Emma Earl, a 2021 Veeva R&D Hero, is developing a culture of improvement at Bayer, or what Japanese business strategists have long called Kaizen, in its clinical operations.

Jim Reilly

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