EMC Documentum Electronic Trial Master File (eTMF)

As the latest addition to the developing solution portfolio of Documentum Life Sciences Solution Suite EMC developed the auxiliary software solution of research divisions of the companies for management of templates of clinical trials and registration of data on medical practice of EMC Documentum for Life Sciences eTMF.

Management

• The management system of eTMF facilitates compliance of documents to clinical practice (Good Clinical Practice - GCP), at the same time in accuracy implements model of document flow of DIA association (Drug Information Association) TMF v2.0.

• allows the medico-pharmaceutical organizations easily and to effectively control and synchronize components of researches
• helps to control the course of drawing up documentation on clinical trials
• provides quick and reliable access to documentation, both during clinical trials, and after their termination
• the structure of the new version includes functions of automatic synchronization of changes in documents
• expanded functions of search and the improved functions of virtual editing documents for big difficult documents also were a part of a product

The new version gives enhanced capabilities for simplification and acceleration of planning of difficult clinical trials (for example, simple functions for creation and tracking of plans of clinical trials by means of Microsoft Excel and for management of hierarchy of files at the level of products, researches, the countries and platforms for ensuring coordination of different clinical trials).