Today we are incredibly excited to announce that Paul Fenton, Montrium President & CEO will be presenting at the upcoming Health Sciences Records & Archiving Association Annual Conference in Brighton, England on April 26th. As a key leader in the TMF Reference Model Initiative, Paul has been actively involved in spearheading the new TMF Exchange Mechanism to facilitate the exchange and interoperability of TMF content and systems.
The transition from paper to an eTMF brings a whole host benefits to a research organization, helping them to increase productivity and meet the demands of an ever-changing regulatory landscape.
However, eTMF comes with its own set of challenges. Developments in technology are driven by the desire to innovate—they wait for no one, they are fast-paced, and, because of this, they are disruptive. On the other hand, the development of industry standards and updates to regulation involve many stakeholders and lengthy review processes, and often trail well behind innovations in technology.
The life sciences industry has seen a progressive increase in the number of companies choosing to manage their Trial Master File (TMF) via electronic systems; encouraging but not really surprising to anyone who—most likely at the end of a trial—has experienced the woes and stress of reconciling a paper TMF. At the same time, the number of companies and organizations that are offering solutions and products for managing eTMF has exploded in kind.
To attend the event, register here: https://the-hsraa.org/overview-hsraa-annual-conference-2018-2
Leave A Comment