Ennov is pleased to announce that we are sponsoring the Trial Master File Summit being held in West Palm Beach, FL on March 20-22, 2023.
The event welcomes Life science professionals from pharmaceuticals, biotech, and medical device organizations and provides with TMF community with actionable strategies and useful tools needed to return to work informed, equipped, and inspired to guide their organization’s TMF to its full potential!
Ennov’s Kathie Clark, Product Director, CTMS and eTMF and member of the TMF Reference Model Steering Committee will present on the topic:
ICH M11 and the Future of the TMF
The ICH is currently preparing guidance on a standardized, structured electronic protocol (CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL (CESHARP). This session will review the basics of the Guideline and discuss how such an electronic standard could affect various aspects of TMF planning, organization, and inspection in the coming years.
Be sure to stop by the Ennov booth to learn how Ennov eTMF goes beyond just the sharing of documents to ensure a single source of truth, automate processes, decrease risk and improve awareness of status and compliance.