2nd Trial Master File Summit
24 Jan 2013 - 25 Jan 2013 - VA, USA
Improving Quality in your TMF Documentation through a Compliant Centralized Filing System
During the clinical trials phase of a products’ life cycle involving patients, the pharmaceutical industry is required to create and maintains a trial master file (TMF) comprised of upwards of 100s of thousands and even approach 1 million in longer trials of required clinical documentations. These documents are designed to demonstrate compliance to an investigator or sponsor, and to maintain Good Clinical Practice standards.
Currently through a demand to improve TMF quality, the industry is making a transformation from eTMF had become easier for an organization to create a centralized eTMF system that is affordable, flexible, and can act as a real-time trial monitoring tool. eTMFs have also created advantages such as reducing clutter, enabling new organizational capabilities, and facilitating trial document quality management of a multi-site trial on a global scale.
At ExL Pharma’s 2nd Trial Master File Summit will provide industry professionals a forum to discuss best practices of data management filing through paper TMF, eTMF, and hybrid systems. Additionally the event will allow TMF Process Owners, Quality, Clinical, Regulatory, and Information. Technology professionals who are responsible for TMF to share insights and
best practices to facilitate successful TMF management. Clinical trial leaders can focus on advancing science to improve and save lives by more effectively using advanced TMF management concepts and management and regulatory considerations.