This guide is designed to help life science organizations make an informed decision around a complex question: whether to outsource some or all of their Trial Master File management to a third-party provider. Based on Phlexglobal’s extensive experience encompassing TMF software, services, and compliance best practices, we have put together a pragmatic set of criteria to consider before you make this critical decision.
The questions and content in this guide will provide a solid framework for discussion, and set out key requirements to look for in a provider. It’s important to consider as many of these aspects as possible in advance – simply by asking the right questions, the process will go more smoothly and you will avoid some of the common pitfalls companies make when outsourcing TMF management.