Phlexglobal will be sponsoring, exhibiting and speaking at the 4th Annual European Trial Master File Summit from 12-13 October 2015 in London, UK.
Trial Master File professionals must head up the processes to maintain hundreds of thousands of pages of clinical documentation.
It is up to you to collect this information and ensure it is both accessible to inspectors and archived in the most cost-effective manner.
This is a daunting task but important for the patient and sponsor companies to ensure they are ready for inspection and that GCP guidance is being followed.
The industry is constantly asking which documents should be included in TMF and how to make the switch to an eTMF system, which could result in greater ease of archiving for TMF professionals.
While implementing eTMF can be costly and training employees can be difficult, you can ensure real-time monitoring of data through eTMFs. This will result in better management of CRO partners and ease the inspection process for sponsor companies.
At ExL Pharma’s 4th European Trial Master File Summit, TMF experts will discuss best practices for developing, managing and monitoring a TMF process that is regulatory compliant for audits and inspections.
TMF process owners, quality assurance, clinical, regulatory and information technology professionals who are responsible for TMF will share insights and best practices to facilitate successful TMF management.