Carlos Orantes, CEO, Alcanza
Last weekend, sites, sponsors, CROs and providers gathered in Hollywood, Florida for the annual event that is now recognized as “the site’s meeting,” aka the SCRS annual Global Site Solutions Summit (GSSS).
At this year’s event, stand-out themes included research diversity, resourcing strategies and financial management, with a host of panel discussions and presentations offering solutions to longstanding challenges around these areas.
I had the opportunity to participate in three panel discussions that addressed these topics – together with representatives from other site networks, research institutions, sponsors and CROs.
While diversity is a perennial theme at industry conferences, GSSS discussion focused on how sponsors are preparing now, in advance of more explicit guidance from FDA. After the epidemiology of an early-stage investigational product is established, a common practice that many sponsors are adopting involve therapeutic-specific study templates – that address how trial components will address inclusion of underrepresented racial and ethnic populations.
Regulatory experts advise creating diversity plans early in clinical development. When considering site selection criteria for reaching new patient populations, this is an area where embedded sites and partnerships can help reach and enroll more ethnically diverse patients, and a strategy that Alcanza has successfully deployed to expand research opportunities into local communities for broader representation.
Discussion also revealed a lack of consistent approaches for tracking participant diversity and demographic data. There are many opportunities for sites, sponsors and CROs to align on metrics and terminology. Panelists were united in their belief that clarity from FDA guidance can’t arrive soon enough!
Resourcing is a major challenge that impacts sites of all sizes and specialties, and a hot discussion topic at all industry events. With almost 30 years of experience in this space, I can definitely say that turnover is inevitable. On a site level, we must look critically at the reasons behind why people leave and come up with better ways to develop and retain talent to support the next generation of medicine. Site representatives discussed their recent successes with recruiting staff from ancillary healthcare sectors and entry-level staff from other sectors including hospitality and customer-service focused businesses. Alcanza has adopted similar strategies in response to post-pandemic staffing shortages and has strengthened its internal onboard and training capabilities for clinical staff and investigators.
Other discussions reinforced the challenges that sites face with generating sufficient cash flow, a reality that has been recently exacerbated by higher rates of cancellations and study delays. Good business practices now mandate more sophisticated forecasting. In the absence of reliable industry-wide pipeline intelligence, sites must scrutinize their existing backlog and urge sponsors to share pipeline priorities as part of formal planning and ongoing collaboration. Incidentally, this is a topic Alcanza has written about extensively. Early collaboration with pipeline planning offers multiple long-term benefits for sites, sponsors and CROs, impacting resource utilization, training and technology efficiencies.
On the topic of on-time payments, panelists affirmed that simple solutions and regular communication may offer the best remedy. Routine communication among key stakeholders (sites, sponsors and CROs) can clarify confusion among payment triggers, such as… “Does the EDC entry or the monitoring visit report trigger a payment event?”
Panelists expressed how a routine failure to maintain points of contact at the site or CRO levels obstructs communication and impedes quick resolution of issues that impact timely payments. Even when picking up the phone may be the fastest path to quick resolution, a CRA change, and outdated contact information can introduce needless delays. Panel discussion referenced the utility of solutions like Versa Trial to maintain updated study contact information and help reduce site burden.
Overall, the rise of site burden and growing need for meaningful collaboration speaks volumes about the value of site networks. The centralization of business development, human resources, finance, IT and patient outreach reduce administrative burden and allow site staff to re-direct energy and focus into patient engagement and care.
In addition to growth and expansion of the internal Alcanza network, I’m proud that some our brands are part of hyperCORE International and our Accel brand is part of Elite Research Network for all these reasons and the strong relationships that come with collaboration.
Finally, it was encouraging to see the high attendance, especially of first-time attendees, and the high energy levels at this important event. The momentum that GSSS generates is essential to accelerating the delivery of inclusive research and promising new medicines forward.
