Clinical research organization (CRO) Pharmaceutical Product Development, LLC (PPD) has launched an advanced clinical research site training, coaching and support offering called “SiteCoach.” The CRO seeks to address the fundamental problem in clinical research that not enough clinical sites have the support, expertise and wherewithal the for regulatory, business and administrative aspects of running clinical trials. Far too many clinical investigational sites fall in the “one and done” category hence limiting the ability to ensure that new advanced medicines can be tested for safety and efficacy.
What is SiteCoach?
A service offering that includes appropriate tools and comprehensive training at each critical stage of the clinical trials process. Training is conducted between site qualification and activation, before the study, during the study and after the study to provide a full continuum of support. Training can be delivered virtually, face-to-face or combined, as needed. Features include a user-friendly online interface, a learner community portal offering resources and tools, a learner forum and mobile gaming designed to increase learner retention.
Connecting with TransCelerate efforts
PPD has probably made a wise move by “plugging-in-and-playing” with the TransCelerate site qualification and training initiative, which represents a group of the largest pharmaceutical companies. PPD seeks a mutual recognition program for ICH E6 good clinical practice training. TransCelerate has expended time, energy and effort into this mutual recognition program for site personnel.
Pilot Success in Thailand
The pilot program for SiteCoach provides training to new-to-research investigators in remote areas of Thailand whose patients otherwise would not have benefited from participation in a clinical trial. PPD reports that enrollment rates for these sites were 70% or higher and screen failure rates and quality findings were 10% lower than other research sites in this particular study.
Rolling out the Program
PPD reports in their press release that SiteCoach is being adopted by several universities to increase student and faculty capabilities to bolster success in research involving clinical trials. PPD notes that in early deliveries survey results show 89% of trainees found the training to be worthwhile investment and 100% of trainees reported they would be able to apply the knowledge and skills learned to their job.
Partnership with Envision Research (Division of BRF)
PPD has partnered with Envision Research to train rural sites in Louisiana to enable physician practices to participate in clinical research, as well as offer their communities access to additional healthcare options.
A Smart Move if Investing Ongoing in its Future
TrialSite News is often skeptical about marketing press releases but we are quite impressed with where PPD is going with this. A fundamental training and support need exists in the market to support clinical investigational sites. Assuming this program stays accessible and affordable it shows great promise. Follow the link to read there press release.
Call to Action: Learn more about PPD’s SiteCoach here.