Reuniting and Reconnecting at the 2022 Onsemble Conference

Throughout the day on Tuesday, March 29, clinical research professionals arrived at the Westin Savannah Harbor Golf Resort & Spa in Savannah, Georgia. Many were reuniting in person for the first time in two years, some were meeting for the first time, but everyone was anticipating the start of the 2022 Onsemble Conference.

Since 2006, the Advarra-hosted Onsemble Conference has been the premier conference for the research community. This customer-exclusive event brings together research professionals from across the industry to network with one another, collaborate to find solutions, and share experiences with one another.

While many were excited to simply gather together in a shared space rather than virtually, everyone was able to take tangible action items back to their own institutions to implement. Below is a recap of various highlights throughout the conference.

Keynote

To kick the week off, Carrie Nemke, Gadi Saarony, Jonathan Shough, and Jeff Sidell of Advarra shared conference and company updates in the keynote session. With more than 1,300 participants joining in-person or virtually, Nemke highlighted eight different conference tracks, ranging from implementation, to financials, to training.

In his portion of the keynote session, Saarony highlighted the impact of clinical research on the COVID-19 pandemic and how clinical trials have evolved as a result. Since 2020, there has been a 93% increase in decentralized clinical trials (DCTs), and a 28% expected increase in DCTs from 2021 to 2022. This, Saarony noted, calls for better resourcing, diverse representation in trials, and unification of the industry to help reduce site burden through our services, products, and people.

One way to unify the industry is to deliver site-centric technology. Shough presented how encouraging sites to use their own technology – rather than sponsor-imposed – will help accelerate study startup, decrease cost and staff burden, improve visibility across stakeholders, and increase protocol adherence. By empowering sites, supporting the site/participant relationship, and connecting the research ecosystem, we can produce a seamless clinical trial experience for all.

Unveiling a new technology initiative, Sidell presented the Advarra Cloud. Designed to transfer the responsibility of managing computing infrastructure from sites to Advarra and AWS, he outlined how this move enables sites to focus on running clinical trials more efficiently.

Site-Sponsor Consortium

The conference also hosted their first in-person meeting of Advarra’s Site-Sponsor Consortium, a unique collaboration of leading research sites, life sciences companies, and standards bodies. Lead by Shough, Advarra’s President of Technology Solutions, alongside Stuart Cotter, Advarra’s Director of Product Management, members engaged in a variety of discussions addressing key inefficiencies experienced across the clinical research ecosystem. Highlights included industry “Day in the Life” presentations, from representatives across the industry like CSL, Syneos, and University of Florida, as well as a presentation on the importance of standards provided by Rhonda Facile, Vice President of Partnerships at CDISC.

The meeting was the first of many to come, as the Consortium prepares to tackle inefficiencies and connect site and sponsor technology. For many members, the meeting was a riveting reminder of what they all hope to achieve within research, and a tangible example of the impact of candid, transparent discussion. The group ended their session by diving deeper into the standardization and exchange of regulatory packets and greenlight checklists. The next Consortium gathering will take place virtually at the end of the month, where they’ll pick up conversations on regulatory packets, trial master file (TMF) standardization, and study startup.

Keys to Success: Tips for Implementing Advarra EDC

Implementing an electronic data capture (EDC) technology is no small feat, and in their presentation, Matt Brown, Amy Drake, and Kirsten Linsenmeyer shared tips for implementing Advarra EDC across The Ohio State University and The Ohio State University James Comprehensive Cancer Center.

Before implementing enterprise-wide, both the cancer center and the college of medicine didn’t use an integrated EDC system. Because of this, there were major considerations for each group, including meetings, ownership of responsibility between groups, document updates, signatures, and 21 CFR Part 11 compliance.

Through a series of meetings, attendees were able to make decisions on conflicting ideas, workflows, and who would sign off on standard operating procedures (SOPs). Additionally, they needed to update their Advarra eRegulatory Management System (eReg) to use the SOP module for signatures. This included updating reference lists, staff roles, informing regulatory staff of changes, updating administrative staff, and updating eReg for access requests for EDC and eReg.

Once everything was in place for go-live, staff received documentations designed to help them understand testing guides, workflow maps, and, in general, what to know about EDC. They also were able to attend demos and meetings such as general information, step-by-step guides, and guidance for request forms. By providing these documentations and hosting these meetings, staff were led through every step of the process, making implementation easier to understand.

Enhancing Research Conduct Using eConsent

With the rise in remote trials, Wendy Tate of Advarra presented how research staff could operationally enhance a research study through electronic consent (eConsent).

Essentially, eConsent enables research teams to facilitate informed consent over long distances, such as video conference, cell phone, or eConsent platform. This also gives participants a more interactive way to learn about the research study through hyperlinks, images, video, or adjustable font sizes, enabling them to grasp a deeper understanding of the trial. It’s easier for participants to also consult with trusted resources as they go through the consenting process, such as family, friends, or physicians.

Tate outlined the many benefits to research teams as well. Utilizing eConsent reduces the chances of staff finding and using an outdated version of the consent form, or losing consent forms altogether. If a site is able to integrate electronic consent with an eConsent platform, eRegulatory (eReg) management system, or a clinical trial management system (CTMS), it further reduces data entry errors among staff.

While utilizing eConsent can enhance your studies, Tate noted there are programmatic factors to consider, such as if your site has access to the proper technology, or if standard operating procedures (SOPs) are set in place. Additionally, staff will have to think of both study and regulatory considerations, as well as talking to their institutional review board (IRB) in order to fit eConsent into their current workflows.

Beyond sessions like those featured above, attendees enjoyed the invaluable opportunity to connect with and learn from one another. Taking the time to come together as a community is imperative to move the industry forward.

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