Montrium, a leading eRegulatory and eTMF solution provider will be a key conference sponsor for the upcoming eRegulatory Summit 2018 in Lisbon, Portugal. In addition to conference sponsorship, Montrium’s President & CEO Paul Fenton will be leading a session focusing on Continuous TMF Inspection Readiness in Clinical Trials. To learn more about Montrium’s content management platform for life sciences and the suite of applications for eRegulatory and eTMF, please drop by our exhibit in the conference hall to speak to one of our onsite team members.
Here’s a brief run down on the topics Paul will be discussing in the session:
Title: eTMF: The Key to Continuous Inspection Readiness in Clinical Trials
Regulatory authority expectations regarding trial master files are evolving and inspection readiness when using eTMF is on the forefront of most sponsors minds. Achieving TMF inspection readiness can be challenging without the right tools and processes in place. Teams still scramble to locate and organize trial master file content, and prepare effectively for regulatory inspections, often requiring late nights and a great deal of hunting to get ready. This additional pressure on clinical teams and increased risk of issues during inspection could be avoided, through proper planning and use of technology.
In our upcoming presentation, Paul will be exploring how sponsors and CROs can implement a proactive TMF inspection readiness methodology by looking both at your process and the technology you leverage to help you manage TMF content.
The presentation will focus on:
- Evolving expectations of the regulators
- TMF planning to ensure timeliness
- Managing inspections with an eTMF
- Centralizing content through technology
- Challenges of calculating TMF completeness
- Features that your eTMF needs to facilitate inspections