Improving Regulatory Workflows in Study Startup
Improving Regulatory Workflows in Study Startup
Advarra’s Site-Sponsor Consortium seeks to bring life-changing treatments to patients faster through collaboration at scale. As many trial delays occur within the study startup process, Consortium members are turning their attention to investigating the process of exchanging documents between sites and sponsors during study startup.
We’re referring to this process as Secure Document Exchange, as the maintenance, transmission, storage, and signing of these documents is highly-regulated. Specifically, the Consortium is working to identify areas of opportunity or efficiency to improve:
- How to standardize access to and exchange of all study documents
- How document status (ex: signing, delivery, quality controlled, etc.) is tracked and monitored across study stakeholders
- How to integrate technology to better route all documents more efficiently to a sponsor’s eTMF
Everyday Realities of Document Exchange
For many organizations, regulatory management—specifically during study startup— presents significant burden on site teams, study monitors, and more. Consortium members from Duke University know firsthand the daily impact of regulatory workflows and the disconnect between site and sponsor systems:
documents managed in Advarra eRegulatory Management System that may also require duplicate transfer to sponsor systems.
estimated administrative effort of Duke’s research staff’s weekly time spent accessing, navigating, and managing materials and documents in sponsor systems.
Q&A with Stuart Cotter,
Consortium Director
What is one of the key workflows that you’re asking for input on from the Consortium, and why did you choose that workflow?
Accelerating study start-up and more specifically creating a better process of exchanging documents between sites and sponsors. This consortium has proven to me that the reduction in administrative burden is something we can deliver through shared understanding, standards, and integrated technology.
What has surprised you about the feedback you’ve gotten from the Consortium thus far?
To move forward together, we must be willing to discuss what hasn’t worked. I’ve been impressed, and thankful at the openness of those willing to share and critique their own processes so we can find common ground and innovate on where we can break down the ‘this is how we’ve always done it’ barriers that are now just appearing in electronic form vs paper.
Development Updates from the Connected Ecosystem
Advarra’s Longboat Platform unites study stakeholders and centralizes trial activities within one integrated system with content tailored to meet specific study needs. Within the Longboat Site Portal for document exchange, study teams can now exchange, manage, and access sites’ essential protocol documents through one central location throughout the study.
Additional Resources
It’s Time for Sites to “Bring Your Own Technology” (BYOT)
The Bring Your Own Technology philosophy will produce synchronization between sites & sponsors, which improves both care & clinical outcomes.
Utilizing eRegulatory Integrations to Expedite Regulatory Workflows
Learn how key eRegulatory integrations like email, local and central IRBs, and Clinical Trial Management Systems can accelerate study start up, increase compliance, and improve regulatory workflows.
