It is no secret that there are not enough clinical investigational sites to fulfill the robust volume of current clinical research pipelines, let alone imminent new research. This problem occurs not only in the United States, but abroad as for a number of reasons—physicians tend to shy away from becoming a clinical investigator. It is well known that a majority of physicians that become a clinical investigator become one of the “one and done” category. That is, they will participate in one clinical trial, and that’s it after that. The reasons for this hesitance and one and done phenomenon often come down to regulatory and administrative burdens, economics, and associated business development limitations or constraints. But what if these challenges could be solved for physicians—would more of them become and stay clinical investigators?
The issues for the clinical investigators are multifaceted, and a complete analysis is beyond the scope of this summary. But suffice to stay that problems center around the process, people, systems, and economy. If these factors can be addressed and overcome, then the rapidly growing worldwide market for clinical research and trials can be met with growing ranks of ready and able clinical investigators capable of stepping up and meeting the demand. If the industry could even half-way approach this market equilibrium, then the drug development world will enter a new heretofore not experienced productivity boom, leading to more and better medicines for patients worldwide.
An Opportunity to Explore for Sites: SiteVault Free
One of the biggest challenges the site investigator faces are payments and regulatory compliance. Ensuring that a site operates to required laws, regulations, and rules consistently are of paramount concern. The physician must be able to recruit and retain talents, such as site coordinators and regulatory professionals, to support the required mandates (e.g., GcP, ICH, FDA, etc.). Systems play a significant role in this endeavor as do disruptive business models TrialSite News has covered, such as “clinical research as care option” models.
Trialsite News recently praised Veeva for its SiteVault Free model as the right course of action to take for the market. Undoubtedly, some feathers got ruffled internally to secure that kind of model in a high flying, Silicon Valley-based culture driven by a pedal to the metal, full-throttle revenue growth and profits.
With SiteVault Free Veeva is offering up rare behavior of any vendor—a commitment to the bigger picture which in this case is that many small clinical investigator sites don’t sit on vast piles of cash—yet they require compelling technology to support their trials. With access to a highly robust, cloud-based system for all regulatory documentation associated with the trial, even the smallest investigator site can operate with the technology used by the world’s largest biopharma sponsors.
TrialSite News proposes something even more advanced however—what if in addition to SiteVault Free, Veeva could infuse the best practices of a site accreditation, such as the Site Accreditation and Standards Initiative (SASI) with the workflows, vaults, and template libraries within SiteVault Free itself. As sites secure SiteVault Free, they also access a turnkey service for accreditation that improves site productivity, patient safety, and quality—powerful stuff. This would dovetail with the site accreditation wave coming soon. TrialSite News has covered examples of this coming wave with activities in China where CROs are ramping up training and standards for site maturation services.
Contracting & Budgeting a Problem
Another key challenge area for sites include areas of contracting and budgeting. In one industry survey, 70% of sites expressed a negative view of the industry sponsor payment process—investigators have a horrible time trying to get paid on time. Moreover, many places run their finances and contracting in a manual and administratively burdensome manner. They and their staff have their time stolen from patients grappling with administrative tasks to secure payment. Hence why when more than 4,000 sites responded to CenterWatch’s 2019 Global Site Relationship Survey, they rated sponsors and CROs on 40 factors and found the biggest problem was contracting and budgeting.
Specialized payment vendors center their business models on the systems and processing of payments on behalf of investigator sites. Still, despite those available services, the problems of slow payment and other administrative challenges seem to carry on full throttle. Moreover, many of those payment services options add up in cost. They are out of reach for the majority of small sites—these physician operated organizations frequently don’t have surplus profits for outsourcing services.
Veeva now potentially shakes the site technology market up again with their Veeva Vault Payments—a new cloud-based solution that automates payment processing to not only improve efficiency for sponsors and CROs, but also for sites. Vault Payments is seamlessly integrated with the Clinical Trial Master System for faster, easier, processing of payment reimbursement to sites—reducing the burden on investigator sites and encouraging repeat principal investigators while reducing inefficiency for sponsors/CROs. Veeva appears to be investing heavily in the research site—whereas TrialSite News can truly attest, the action is! Veeva’s mission appears quite sincere at this stage—they are parlaying huge financial success from engaging in the big pharma sector and allocating R&D expenditures to the severe challenge of solving problems at the site level. For this, they should be commended.
Call to Action: TrialSite New is vendor-neutral, but will mention any vendor that commits investment to solve problems at the clinical investigator site level as this is of the utmost importance. Hence, we recommend that sites at least learn more about SiteVault Free and Vault Payments—both of which are part of the Veeva Vault Clinical Suite. As always, we emphasize to sites to do their homework—compare different vendors and approaches—including disruptive models where third parties bring the systems and processes as a service to the site—so that the sites can concentrate on what they do best—seeing and caring for patients.