Bridging the Gap: A Standardized Approach to Clinical Trial Document Management

As a clinical research professional, you are constantly asked to accelerate research timelines while the research itself becomes more complex and your resources become more scarce.

Luckily, we are making progress. In this webinar, representatives from the Advarra Site-Sponsor Consortium discuss a standards-based integration and automation of research technology across sites, sponsors, and CROs. The group shares the Consortium’s role in developing Secure Document Exchange and the role of standards in creating seamless process between all stakeholders.

Join us on-demand to hear perspectives from across the industry on how this collaborative, standards-based approach is key to finally addressing the challenge of automating data and document exchange across sites, sponsors, and CROs.

Learning Objectives:

• Understand investigator site file (ISF) and sponsor trial master file (TMF) organization
• Get a site perspective on how we can improve compliance by streamlining interactions between sites and sponsors
• Explore existing standards for ISF and regulatory binders, and how these standards will evolve through the CDISC TMF Reference Model
• Determine actionable steps to take for all research stakeholders to make the connected research ecosystem a success

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