October 15-17 2013 - Montrium will be attending the Annual DIA EDM and ERS/eCTD Conference again this year in San Diego, CA.
We will be exhibiting and look forward to meeting up with colleagues, old and new. In addition, our CEO, Paul Fenton will be presenting a session on empowering the TMF for the 21st Century. 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.