Take a look at what’s inside the guide.

The Shift to Remote Inspections

How the FDA is shifting more to remote inspections and what it means for modern TMF management.

How an eTMF Adds Value

How the eTMF application helps not only manage TMF documentation but provides a platform for process collaboration with CROs and Sponsors.

A Shared Responsibility

Building a hybrid (shared) responsibility model between CRO and Sponsor to manage the eTMF and ensure inspection readiness.

About the Authors

Kari Brown

Kari Brown

Clinical Operations Director, DZS Clinical Services

Kari has extensive experience in project management across various therapeutic areas and study phases. With her ability to lead and positively motivate a team combined with her deep functional expertise, she is an integral and instrumental part of the DZS company.

Barb Mosher Zinck

Barb Mosher Zinck

Marketing Director, Agatha Inc.

Barb has over 10 years of experience helping organizations build marketing programs that align with business goals and drive revenue.

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