eTMF As A Factory: Key eTMF Elements And Practices For High Volume, High-Quality Processing

By Kathie Clark, Senior Director - Offering Management, Orchestrated Content Management

For pharmaceutical companies of all sizes (and the CROS that support them), the eTMF can be a high-volume process involving the management of dozens, or even hundreds, of studies simultaneously. These studies range from small Phase 1 studies of short duration to so-called “megatrials”. A cursory look at the studies in clinicaltrials.gov reveals studies that would result in very large Trial Master Files:

• Daiichi Sankyo’s phase 3 study “Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation (EngageAFTIMI48)” lists 1002 sites in 46 countries; and
• Novartis’ phase 3 study “Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events) (CANTOS)” lists 1557 sites in 40 countries.

Although, smaller companies experience also high volume when running large Phase 3 studies. For example, the Exelixis “Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100 (COMET-1)” is being conducted in 12 countries at 264 sites. A study of this size might conservatively be expected to generate 5000 to 10,000 TMF documents.

Ideally, an eTMF would operate like a well-oiled factory by using highly efficient, repeatable processes to achieve a defined level of quality using the minimum level of time and resources possible. This white paper examines some of the factors that would support making “The eTMF Factory” a reality.