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