To ease frustrations and promote collaboration, electronic TMFs give sponsors and CROs the ability to contribute and access important content in real-time within a centralized and standardized environment. This year, topics at the conference will cover how to improve eTMF workflow through interoperable technologies, use disruptive technologies to improve metrics reporting and efficiency, and put controls in place to meet oversight and monitoring requirements of ICH E6(R2) using a risk-based approach.
What: During the conference, Montrium will be showcasing eTMF Connect, our eTMF solution which helps life sciences companies better manage their clinical trial documentation. Designed using the TMF Reference Model, eTMF Connect allows teams to create and manage all of the essential documents required to streamline their clinical trial management.
Montrium’s CEO Paul Fenton will be presenting a Case Study on “Data-Driven eTMF — Towards Improved Quality, Timeliness, and Completeness” (Wednesday, October 2nd, 2019 at 13:45)
- Ensure quality, timeliness and completeness of eTMF by using operational data to interconnect clinical processes, activities and events
- Gain visibility of what artefacts are required and the lack of triggers present to prompt contributors
- Employ operational data and data management strategies to ensure the highest quality eTMF
- Improve how we predict and manage artefacts through the use of predictive analytics based on central process models and data management techniques