Services
Regulations require a trial master file (TMF) to be created and maintained for a clinical trial. Accovion compiles and files all trial essential documents and information in a coherent format to enable your own ease of access and ready availability for audits and regulatory inspections. TMFs can be created and maintained as paper only or as an additional electronic trial master file (eTMF) format, which enables you to access all documents and information immediately after they were generated.
The Accovion proprietary TMF database system provides an ongoing overview on content, completeness and quality of each essential individual trial document, including all necessary study-specific adjustments.
Accovion’s Clinical Trial Management team tracks and reviews each document and can provide clinical monitors and other parties with comprehensive reports on outstanding documents, inconsistencies between the documents and any other helpful information.
At project closure, the TMF will be transferred to your preferred final archiving location accompanied by a complete and comprehensive table of contents and inventory of all documents and binders to facilitate future access.
Dr. Andree Beckerling
Senior Medical Director
+49 6196 7709-343
