TrialSite News has monitored how industry sponsors and clinical research organizations (CROs) increasingly covet direct engagement with valuable clinical investigational sites. After all, it is these organizations (and their physicians) that directly conduct the research and engage the patients. Recently Veeva launched SiteVault Free, PPD launched SiteCoach and now Parexel has inked a strategic partnership with a leading clinical site association as “Site Engagement Partner.”
It turns out SCRS is on to something special. After they were formed by a truly exceptional person, Christine Pierre, who recently passed away. The organization she founded has continued to grow and extend site influence around the world. Clinical investigational sites directly engage with the patients in most studies—they are the nexus of the clinical trial.
Sites have struggled. The landscape of sites is skewed toward many thousands of small organizations, often run by physicians, that don’t necessarily have the infrastructure, wherewithal, and competency to sustain clinical trial operations. Hence the “one and done” problem is well known in the industry—where a physician/investigator will dedicate the practice to an FDA-controlled study only never to do it again. For a myriad of well-known reasons, it just isn’t worth the bother.
Disruption Coming to Sites
Change is on the horizon. TrialSite News, living up to its name, writes extensively about sites and trials. Organizationally, new models are permeating the site industry, from heavily financed private equity-backed role-ups to global integrated site networks to clinical research as care option enablers—where one party brings the FDA/GCP/ICH E6 know-how, tools and compliance, and clinical services to existing physician networks instantaneously transforming them into a clinical trials player; derivative technology and data-driven models emerge as well.
Technology preference shifts will further disrupt studies, moving them from traditional major site-centric to patient-centric as an explosion of cloud computing, mobile technologies, social network, big data, and AI will move the study closer to the patient as nexus. The site and associated physicians will still be partners in that new world—digitally connected always.
CROs Battle for Mind Share
According to a recent Veeva study, CROs will be conducting ever more of the sponsors’ clinical trials. CROs, which have gone through waves of partnering and even buying sites themselves, have entered this new site engagement era. In fact, TrialSite News just wrote about PPD’s SiteCoach offering.
Now Parexel has inked a partnership with Society for Clinical Research Sites (SCRS) as a “Site Engagement Partner” and lead a number of key initiatives focused on improving patient experience in clinical trials, further underscoring the sites’ symbolic and pragmatic position as trial nexus—the patients come to the doctor. The patient and site (investigator) stakeholder community are absolutely paramount to sponsor and CRO success—playing a pivotal role in bringing new therapies to the market. Undoubtedly Parexel’s own Global Site Solutions team, which maintains a large site database and associated services offering, will capitalize on this partnership.
Parexel & SCRS Initiatives
The CRO and site association will engage on several new initiatives including:
· Parexel will lead “Site Advocacy Group (SAG) on diminishing patient burden in clinical trials, bringing sites and patients together to discuss patient perceptions of methods of reduction of patient encumbrance to participate in clinical trials
Parexel will join SCRS Diversity Initiative to address challenges and opportunities at the site level while exploring the needs of diverse patient populations in clinical research participation around the globe, alongside leading global biopharmaceutical partners.
Founded in 2012 by Christine Pierre, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship, and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit MySCRS.org.Source: Yahoo! Finance