Maintaining an inspection-ready Trial Master File is becoming increasingly burdensome, even for teams with significant resources. For small and mid-sized sponsors, however - with resources often stretched across managing the study as well as the Trial Master File – achieving ongoing TMF quality, completeness, and timeliness can be an overwhelming task. And while outsourcing some aspects of the TMF can help, that in turn creates its own set of challenges.
In this session, our experts walk through a new, full-service TMF management approach implemented by smaller biopharmaceutical companies. By adopting a fixed-fee, turnkey model encompassing everything required for ongoing TMF health, these organizations are achieving high-quality TMF compliance – with far less effort.