The 2017 Site Solutions Summit, held in Boca Raton, FL, brought over 900 clinical research professionals from around the world together to discuss the latest trends in clinical trials, check out innovative technology and network with partnering businesses. As a vendor, Bio-Optronics has been involved with the annual Summit since its first year, and we love having the opportunity to get involved through exhibiting, holding workshops, hosting happy hours and sitting on panels! After a fun, packed few days, here are some of our highlights:
The Summit is a great place to bring the best sites together in one place. In addition to the sessions, the conference offered a multitude of venues for attendees to meet with one another to learn more about the research business and discuss best practices that help sites grow their business and run trials more successfully.
Outside of the many official events, we were proud to continue the networking with our post-reception after party, which we co-hosted with Complion. We were grateful for the opportunity to hear directly from our users, as well as some new contacts, because this one-on-one networking provide invaluable insights into the most important challenges sites face today. This feedback helps us evolve Clinical Conductor and continue to provide valuable content to the marketplace – like our webinars!
Making the Most of Recruitment
In the sessions surrounding patient recruitment, we learned that some sites are extremely innovative (and extremely fearless) when it comes to new and innovative ways to recruit and enroll patients. Some groundbreaking ways to recruit included outreach programs, embedding research staff with community physicians, advance social media tactics, leveraging patient advocacy blogs and live streams. Our team found this revelation exciting, because our sites’ desire to enhance their operations inspires us to continue to do new things in the CTMS realm. What’s more, there were some great “recruitment” (some of these guys are really bringing new ideas to the table) providers next to us in the exhibit hall, including Acurian, The Patient Recruiting Agency, Antidote, Research Hive and more. We’re big fans of integrating with great technology partners that our users love – so let us know if you have an idea on how a Clinical Conductor CTMS Integration can help your site.
A major topic of the Site Solutions Summit surrounded an emerging technology – eSource. Vendors have existed for some time, but there were some new players in the exhibit hall, and several talks were aligned on the topic of better understanding eSource. There were many pro-eSource sites and speakers whose arguments clearly laid out the consistency and efficiency gains sites could gain from owning their own eSource system. As is always the case when source data is covered, the process to communicate that source data to a Sponsor’s or CRO’s EDC comes into question. Why would a Sponsor integrate to a system a specific site owns? There is risk that a site might be doing the same type of double entry that they currently have to do with paper source.
The confusion surrounding eSource also created some healthy discussion surrounding compliance – with 21 CFR Part 11, GCP and HIPAA. These regulations and best practice standards demand a lot of sites, and following all of them is life or death for sites. With the addition of new systems in the marketplace, the regulatory side of the business is a little behind. 21 CFR Part 11 has some information on the role of electronic source, but more encompassing guidelines are needed to truly clear things up for research sites surrounding eSource software and maintaining compliance. A lot of the confusion centered around on vendor’s capabilities to comply with these regulations, which systems need to be compliant with what regulations, and who is ultimately responsible if a vendor’s processes fail to comply. Sites must be diligent when evaluating solutions and ask the right questions. Some vendors might not be required to comply (i.e. CTMS doesn’t handle source data and does not need to comply with 21 CRF Part 11) and some vendors might be lax in their documentation (a major red flag if they do have to comply with regulations).
After a few days of talking with users, we wanted to offer some clarifications. One of our partners, George Gasparis of the PEER Consulting Group will join us on December 13th at 3PM Eastern to present “Ensuring Data Integrity, Security, and Confidentiality of Research Data.” Sign up here!
Overall, we had a great time at the 2017 Site Solutions Summit, and we already are working with their team to make 2018 an even more exciting and full of knowledgeable best practices. We will see you there!