Full-Service vs. Functional Service Models in Clinical Trials

When it comes to clinical trial execution, is it better to use a full-service solution or a functional service model? For many clinical trial sponsors, the answer is both.

“From small start-ups to large, established organizations, all companies are looking for flexibility and scalability,” notes Craig Cancro, business development manager for EASi Sciences. “By aligning the solution or blend of solutions with the needs of each specific trial, companies can be strategic about how they leverage their core capabilities and deploy their additional resources.”

This perspective was echoed in The Avoca Group’s 2017 Industry Report, which informed a recent panel presentation at DIA2018, the Drug Information Association's annual conference. The presentation, moderated by Mitchell A. Katz, PhD, focused on an issue that resonates in a time of scarce resources and nearly endless needs: “Does Sourcing Strategy Matter? Executives Debate the Influence of Outsourcing Model on Clinical Trial Execution.”

Other panelists included David M. Johnston, PhD, executive vice president of clinical development for PPD; John Oidtman, senior vice president and head of global clinical operations for EMD Serono Inc.; and Jeremy G. Chadwick, PhD, MSc, group vice president of clinical development operations for Shire.

The Avoca study, which represented both sponsor and provider organizations, found that nearly 60 percent of respondents representing sponsor organizations reported primarily using a functional approach to outsourcing. Of those companies that outsourced functions, field monitoring, clinical trial management and data management were the most frequently outsourced.

Outlook on risk-based monitoring
The presentation also noted that challenges are arising as the industry shifts to a focus on risk-based approaches, with these findings from the Avoca survey:

Team challenges
One respondent indicated that teams seemed to find it difficult to shift from a focus on timeline and budget framework to one based on assessing quality risks.

Another noted that broad-based acceptance of the new approach was necessary from all functional parties, noting that they needed a deep understanding in order to commit to the switch and allocated the needed resources to be applied in order to get it off the ground.

Process challenges
A third respondent pointed to the challenges involved in bringing different data sources together into one risk-based management viewpoint, as well of the difficulties of retroactively applying risk-based approaches to legacy studies where the study setup was not conducive to data integration.

“There is no one-size-fits-all method to conducting clinical trials,” says Cancro. ”At EASi Sciences, that’s why we take a consultative approach on each engagement to find out the true needs and determine how to make the best fit.”

If you’d like to learn more about how EASi Sciences can help you manage your clinical trials in a cost-effective way, contact us now.