Andrew Schafer

Every service provider wants their customers to be satisfied with a completed engagement. In that case, knowing what drives customer satisfaction with an outsourced project would be helpful to know, right? Industry Standard Research’s 

Late Phase Study Trends and Market Outlook (2016-2020)

 report digs into key factors behind customer satisfaction as well as many other dynamics within the Late Phase market.	 	Late Phase decision-makers rank 

 timelines management as the attribute that contributes most to a sponsor’s satisfaction with a CRO’s Late Phase services. The provider must deliver according to timelines to have a happy sponsor at the end of a project. Following this is 

, another metric tied to timeline efficiency during a project. If sites and patients cannot be recruited in an effective and efficient manner, both timelines and study budgets will suffer, resulting in a less than pleased customer.	 	Drivers for CRO selection and drivers for satisfaction do not necessarily go hand in hand. The reasons why a CRO is chosen for work may be very different from what will make a sponsor feel satisfied with a finished project. While 

 is the most important driver of sponsor satisfaction, a similar attribute, 

Confidence the provider will meet timelines

, is only middle-of-the-road when it comes to importance in the provider selection process. A similar example may be selecting a handyman to complete odd jobs around your house. You might hire a handyman based on their experience and knowledge but if that handyman takes a month to fix a leaky faucet, you are not going to be a satisfied customer.	 	

“In your experience with CROs and Late Phase services, what usually drives your satisfaction with CRO performance? Rank the following from most important (number 1) to least important (number 8) to your satisfaction with CRO performance.”

	 	ISR has also gathered insights regarding a host of other topics in the Late Phase space including:	

		Late Phase company spend for the past 12 months and projected spend in 2020 by study design (Interventional trials and Observational research) and by study type (Post-marketing Safety studies, Health Economics and Outcomes Research, and Expanded Access studies)

		Outsourced proportions of Late Phase work for the past 12 months and projected proportions in 2020 by study design and study type

		Key decision-makers for various components of the Late Phase study outsourcing process

		Selection drivers for providers across multiple types of Late Phase studies

		Late Phase trends including the importance of technology, the pervasiveness of EMR data, the global nature of studies, and the use of existing vs. newly collected, purpose-driven data

 report is designed to assist those interested in the Late Phase market in not only remaining current with market happenings but in getting a jump on what the market is expected to look like in 2020. Learn more about the report at: 

https://www.isrreports.com/reports/late-phase-study-trends-market-outlook-2016-2020/

Articles

This recent report explores key factors behind customer satisfaction and other dynamics within the Late Phase market.

Late Phase Study Trends

We can’t read the future, but we can certainly help you make smart decisions heading into it. Industry Standard Research (ISR) has come out with a new report that shines a light on both the current state of the Phase II/III clinical trial market as well as its anticipated direction into 2020. “Phase II/III Study Trends and Market Outlook (2016-2020)” contains analysis of emerging trends, Phase II/III spend, and outsourcing behaviors that are expected to shape this realm in the coming years. Both sponsors and service providers will gain information they can utilize to situate themselves effectively for the expected twists and turns in a future market.  	 	One important take-away from this report concerns the increasing relevance of the developing world in the Phase II/III sphere. Decision-makers foresee a notable shift of Phase II/III studies from developed markets into emerging market regions in the coming years.	 	

Increases are also anticipated for emerging market patient recruitment, of which further analysis can be found in the report. These findings indicate that the future of the Phase II/III market will likely be marked by a change in regional demographics and terrains. The expected trend will call for a strong understanding of clinical spaces across global territories, and an increased cultural competence moving forward in Phase II/III endeavors. Altogether, the findings in this report paint a robust picture of foreseen market behavior for industry decision-makers. 	 	

“Phase II/III Study Trends and Market Outlook (2016-2020)”

 provides in-depth accounts from 112 high-level pharmaceutical and biotech decision-makers responsible for Phase II/III drug development activities within their companies.  For sponsors, use this report to know what your industry peers expect for their business direction and study investments, and understand how your company’s strategy compares to that of your competition. 

, the report will inform you of the capabilities and services expected to be sought in a future Phase II/III market. Move forward knowing where to bolster your capacity. 	 	So stay ahead of the game and make informed decisions for your business’s future. More information on ISR’s “Phase II/III Study Trends and Market Outlook (2016-2020)” can be found at: 

https://www.isrreports.com/reports/phase-iiiii-study-trends-and-market-outlook/

Report shines light on the current state of the Phase II/III clinical trial market and its anticipated direction into 2020.

Phase II-III Market Dynamics

	We all need help sometimes. For pharmaceutical companies, this often comes in the form of a reliable and competent contract research organization.  The sweeping presence of CROs across the pharmaceutical landscape opens numerous opportunities for sponsors and providers looking to begin or continue collaboration in clinical development. With ever-increasing procedural complexity of clinical development activities, provider outsourcing becomes a powerful tool. However, one size does not fit all when it comes to the best outsourcing philosophy for a sponsor’s clinical development needs and specifications. Priorities ranging from budget to emerging market reach greatly impact the optimal outsourcing model for the job. ISR’s

 Clinical Development Outsourcing Models (2

helps pharmaceutical sponsors gain a comprehensive understanding of how to identify the outsourcing model most compatible with the priorities of their company. CROs will understand current user perspectives on a number of outsourcing models and arm themselves with the knowledge and insight to succeed going forward in their clinical work. 

Clinical Development Outsourcing Models (2

 provides detailed insight into sponsors’ selection drivers, usage, and overall experience/satisfaction amongst seven outsourcing models. 107 respondents were surveyed for this report, all of whom must 1) work at a pharmaceutical or biotechnology company with an annual R&D expenditure of at least 100 million dollars, 2) have responsibility for outsourcing clinical trials, and 3) be sufficiently knowledgeable about their company’s clinical development outsourcing model.

	While respondents report a generally high level of outsourcing within their company, the level of reported satisfaction with their current provider model adds an important layer to consider. Indeed, findings indicate that a substantial proportion of respondents are not fully satisfied with their CRO model. Only 35% of those surveyed 

that their company has found the ideal outsourcing model.

	In Search of the Ideal Outsourcing Model

	The consistently high use of outsourcing in clinical development work speaks to a deep and ongoing relationship between pharmaceutical sponsors and CROs. However, the reservations voiced by the majority of respondents indicate, at a high level, that many sponsor organizations are still in search of a suitable outsourcing method for their clinical development needs. For sponsors, you have a number of outsourcing approaches to consider when deciding on the type of model that will best fit your clinical development needs. Use this report to understand the nuances of each to better suit your requirements. For service providers, the report findings will provide insight concerning the aspects of clinical development work that pharmaceutical companies hold highly when choosing an outsourcing model. Applying this information will enable you to work seamlessly with your sponsor by anticipating their needs accordingly.

	The nature of outsourced clinical development activity today is a multi-fold process that begins with a clear understanding of the CRO’s capabilities and the sponsor’s clinical development needs. The ability to recognize the optimal outsourcing model for a sponsor’s development work is key in creating productive, efficient relationships between parties. ISR’s 

 report provides a comprehensive means for sponsors and providers to enter into clinical development activity with a sense of confidence in their outsourced approach.

 report, please visit ISR’s report page at: 

http://www.isrreports.com/reports/clinical-development-outsourcing-models-2nd-edition/

Andrew Schafer is the President of Industry Standard Research.

We all need help sometimes. For pharmaceutical companies, this often comes in the form of a reliable and competent contract research organization.

Only 35% of Sponsors Have Met Their Outsourcing Match

	Accuracy in data capture methods has always been and will continue to be a foremost necessity in pharmaceutical clinical trials. It is therefore no surprise that the markets for Electronic Data Capture (EDC), Electronic Clinical Outcome Assessments (eCOA), and Electronic Patient Reported Outcomes (ePRO) are growing given their capability to collect large amounts of data while simultaneously ensuring high quality. ISR’s

 EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015) 

report shines a light on this increasing technological trend by providing a greater understanding of EDC and eCOA/ePRO penetration in pharmaceutical markets. Sponsors, CROs, and technology providers will gain perspective on how to situate themselves in this market.

EDC and eCOA/ePRO Market Dynamic and Service Provider Performance

 offers a view of provider performance on a number of core attributes and gives a close-up perspective of sponsor, CRO, and clinical site service experience with EDC and eCOA/ePRO organizations. Data were collected from 166 respondents representing 3 groups: study sponsor companies, CROs, and clinical research sites.  An important take-away from this research concerns the increasing acceptance and use of EDC and eCOA/ePRO technologies amongst sponsor companies and CROs. Findings show that 91% of respondents exhibit a greater preference towards EDC than paper CRFs, a preference increase of almost 15 percentage points from two years earlier. Similarly, 86% of respondents report a preference of eCOA/ePRO over paper diaries compared to a 61% preference in 2013. The majority of respondent’s reports that they will further increase their use of these technologies in the coming years.  

	Such a vast difference in the preference between electronic and paper-based methods not only indicates a realization of the potential benefits gained through the use of electronic technologies, but also points to a fairly clear gravitation away from paper-based methods. This trend of increased acceptance and usage has several implications for both sponsor/CRO companies and technology providers. 

, be aware of growing demands for technological services within the clinical trial arena. Prepare for additional adoption of your services and possible expansion of your sponsor’s preferred provider list. 

be sure that you have an understanding of the breadth of providers available in your use of data collection technologies. Our report is available in order to provide a clear sense of the best provider for your needs and area of focus. 

	Understanding the emerging area of electronic data collection technologies is a necessary step towards navigating the changing landscape of pharmaceutical clinical trials. The efficiency and quality provided by EDC and eCOA/ePRO allows providers and sponsors alike to move forward with a sense of assurance in their work

 EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015)

Accuracy in data capture methods has always been and will continue to be a foremost necessity in pharmaceutical clinical trials.

eCOA and ePRO Provide Accuracy in Data Capture

	It is well known within the industry that being on a sponsor’s preferred provider list affords a critical leg up to providers hoping to win business. Phase II/III work is no exception. In the 7

 edition of Industry Standard Research’s 

CRO Quality Benchmarking - Phase II/III Service Providers

 report, ISR digs a bit deeper into the dynamics of preferred provider lists and how these lists affect CRO selection for Phase II/III studies.

“Does your company have formal preferred provider agreements for Phase II/III services?” 

	Two-thirds of respondents relay that their company utilizes formal preferred provider agreements for their Phase II/III work.  However, when these data are examined by company size, it becomes obvious that large sponsor companies rely on these lists much more so than their smaller counterparts.  83% of large sponsor organizations utilize PPAs compared to 53% of mid-size sponsors and only 14% of small sponsors.  CROs would do well to recognize that fighting for a spot on the preferred provider list at large organizations is a critical undertaking but might not even be an available option at the mid-size and smaller companies. 

	ISR also collected insights into how preferred provider lists impact the criteria used to select a CRO for Phase II/III work to test the hypothesis that providers are gauged differently based on whether the sponsor company (a) is selecting a CRO from a preferred provider list, (b) has a list of preferred providers but is selecting a provider not on that list, or (c) does not have a preferred provider list. Though some attributes such as 

 are considered important regardless of the decision-making scenario, the data have uncovered meaningful differences regarding selection drivers in each of the aforementioned scenarios.

	For example, among respondents who are selecting among their preferred providers, 

 does not crack the top four most important attributes when selecting a Phase II/III provider while it ranks as more important when sponsors are selecting a non-preferred provider or when they do not use PPAs. ISR postulates this is due to the sponsor organization already having become comfortable with the CROs’ therapeutic expertise during the process of adding each provider to the preferred provider list.  This means when a CRO is bidding for work in a situation where it is already on the preferred provider list, the CRO may not need to spend significant time convincing the decision-making team of its expertise in the desired therapy area but can instead focus on featuring other critical capabilities.

	ISR provides further analysis regarding selection criteria and preferred provider dynamics as well as detailed service provider performance metrics in its 

 It is well known within the industry that being on a sponsor’s preferred provider list affords a critical leg up to providers hoping to win business. Phase II/III work is no exception. In the 7th edition of Industry Standard Research’s CRO Quality Benchmarking - Phase II/III Service Providers report, ISR digs a bit deeper into the dynamics of preferred provider lists and how these lists affect CRO selection for Phase II/III studies.

CRO Quality Benchmarking

	Despite the substantial difficulties associated with orphan drug trial recruitment, this segment of the drug development market is booming.  By 2020, orphan drug sales are expected to make up 19% of prescription drug sales, excluding generics.  In ISR’s 

Orphan Drug Market Dynamics and Patient Recruitment Best Practices 

report, ISR provides an overview of the orphan drug development market as well as how to best drive patient recruitment in an area of drug development in which drug developers do not want to be left behind. 

report, ISR interviewed 10 orphan drug development experts and collected quantitative data from 96 survey respondents from pharma companies that develop orphan drug compounds.  One of the takeaways featured in the report and consistently mentioned by interviewees is the varying preference for orphan drug experience.  The degree of this preference is driven by the type of work that is being outsourced.  The more logistically driven the outsourcing components, the more advantageous it is to seek third-party providers with orphan drug experience.  However, if the components being outsourced are more medically driven, targeting providers with therapeutic expertise is advantageous--particularly since regulations are therapeutically focused.

“If your company were to outsource an orphan drug/ rare disease trial, would it prefer a CRO that….”

	In all cases, orphan drug experience was preferred by a lower percentage of respondents than the alternative (therapeutic experience and global experience).  The takeaway for sponsors is that they should consider exactly what aspects of the clinical trial are being outsourced.  If the sponsor plans to outsource the advertising, marketing, and recruitment of an orphan drug trial, ISR found that it may be worth exploring the option of working with a company that specializes in orphan drug trial recruitment--a company that knows the best practices for reaching these patients--as opposed to the medical expertise required to treat them.  What this means for CROs and recruitment specialty providers is 

 that orphan drug experience does not matter, but that therapeutic expertise, and global operations capabilities should not be abandoned from your positioning in exchange for orphan drug experience.  Framing orphan expertise almost as if it is an additional therapeutic area is one way ISR found companies have included orphan drug experience as a service offering.

	The recruitment of patients for orphan drug trials adds levels of complexity to the already difficult process of patient recruitment.  Navigating the space as a sponsor, CRO, or specialty provider requires careful consideration of what activities need to be outsourced, which recruitment outlets need to be utilized, and how to navigate an often complicated regulatory environment.  ISR’s 

report explores these topics and further provides industry recommendations and best practices for those involved in the intrinsically onerous task of orphan drug trial patient recruitment.

Despite the substantial difficulties associated with orphan drug trial recruitment, this segment of the drug development market is booming.