14th Annual DIA Conference on European Electronic Document Management

Montrium is a regular attendee of this niche conference on EDM, and once again this year we will be exhibiting.

In addition, our CEO, Paul Fenton will be presenting a session on empowering the TMF for the 21st Century. He will also be session chair for the cloud computing presentations. We look forward to seeing you all there!

Synopsis: Empowering the TMF for the 21st century

Traditionally the TMF has been considered a collection of documents that needed to be collated as part of the regulatory requirements of a clinical study. Although this continues to be the case, the increasing use of electronic trial master files and more integrated clinical systems offers us new opportunities for a more holistic and real-time view over clinical trial activities. Notably, we are seeing the emergence of clinical data warehouses which allow for the integration of all clinical trial data and documents into one single database. This in turn can be used to produce a more interactive and complete picture of study events by combining eTMF document metadata, clinical data from EDC and clinical trial management information from CTMS. This approach allows us to improve our ability to ascertain TMF completeness and perform TMF audits whilst also allowing for more comprehensive trial conduct information to drive better decision making and clinical processes. The use of business intelligence tools will also improve access and synthesis of information and the viewing of the eTMF in different dimensions, and will allow for a risk based approach to TMF QC.