By Ann Neuer
October 30, 2012 | The recently held annual Site Solutions Summit* was a high energy gathering of 500 clinical trial professionals culminating with a big announcement—the formation of the Society for Clinical Research Sites (SCRS). This new trade association is intended to provide a much-needed collective voice and a community for global investigative sites, which are anxious for a place at the table as the clinical trials industry works to improve operational efficiency.
Industry veteran Christine Pierre, founder of the Site Solutions Summit and SCRS President, notes that sites play a major role in the clinical trials process, and “for too long, they have been the silent partner in the research enterprise. But no longer will they be passive participants. Going forward, sites will become active partners in the industry’s dialogues and solutions through the voice of SCRS,” Pierre comments.
In one of her presentations at the Summit, she listed the many industry-wide initiatives working to bring meaningful change to this complex industry, yet few have included sites in the discussion. Considering that sites actually conduct the clinical trials on behalf of commercial and non-commercial sponsors, it’s surprising that input from this critical resource has been overlooked for so long. According to Pierre, “SCRS will provide the site's perspective to these industry groups looking to solve many research related issues, such as protocol complexity, patient safety, and expanding use of technology.”
Without a doubt, announcement of SCRS was the meeting’s big attention-grabber. To keep the momentum going, a white paper entitled, Better Payment Terms for Sites: An Industry Imperative, was circulated to all attendees. The white paper, which describes the critical importance of paying sites monthly to facilitate fiscal viability instead of the current practice of paying quarterly, was the first initiative of SCRS. It also reflects one of its goals, which is to educate the industry about site-related issues.
To fuel the education process, SCRS will produce scholarly white papers periodically on topics critical to the well being of sites and to clinical trials stakeholders so they can take informed action and change industry practices. Other parts of the SCRS mission include advocacy; creating an opportunity for sites and sponsors to connect; and mentoring of new sites, with an emphasis on operational excellence. Furthermore, SCRS will host the first site database in which enrollment and FDA audit findings will be compiled on all its members. This cross sectional database of site performance should be a valuable asset to the industry.
A number of exhibitors at the Site Solutions Summit first heard about the launch of SCRS at the meeting. Zaher El-Assi, General Manager eClinical for Merge Healthcare, a technology provider, was among them and says, “One of the things that came out of the meeting and the announcement about SCRS is that sites that invest the time to learn from others and invest in infrastructure are more successful clinical research sites. SCRS will bring these sites together so they can learn from each other.”
|Ellen Kelso, Goodwyn IRB
El-Assi explains further that his company has a major commitment to the well-being of sites. “Despite the fact that we’ve been selling to CROs and sponsors for 17 years, 90% of our users are the sites. We have a user base of 40,000 to 50,000 individuals at sites across the globe, representing 8,000 unique sites in 81 countries.” Earlier this year, Merge bought StudyManager (renamed Merge CTMS for Investigators), the clinical trial management system, because it was the first product of its kind specifically focused on the site. “In terms of budget, Merge CTMS provides a platform for sites to be more successful financially by helping them identify and recover funds they are owed among many other critical site-related processes.”
Another exhibitor, Ellen Kelso, CEO of Goodwyn IRB, also learned about SCRS at the Summit. “I see the work of SCRS as establishing a dialogue where one has been sorely needed. From an IRB perspective, in order for the ethos of the clinical research community to be complete, you need a voice from every component, and previously this was a missing component With SRCS, sites will get a voice and will be able to be partners in the process,” says Kelso.
According to Kelso, Goodwyn IRB, the first all electronic IRB, works routinely and collaboratively with sites and sees her company’s role as instigating best practices and helping sites improve their output. “We walk hand-in-hand with sites and help them learn to operate cleanly, efficiently, and ‘compliantly’. Sites want to do good work, and we help them achieve that, and that sense of achievement is its own motivator.” Kelso adds.
The 2013 Site Solutions Summit will take place on Amelia Island, Florida next mid-October.
* Site Solutions Summit, Oct 12-14, 2012, Palm Beach Gardens, Florida