Whitepaper: Understanding CTIS Guidelines & Process Implications
In January of 2023, CTIS will become the required portal for all new and ongoing clinical trials in the European Union.
This whitepaper will cover these key topics:
- What is the CTIS...
Inspection Readiness: Is Your Trial Documentation Complete?
The Trial Master File (TMF) conveys a study's chronology, and regulatory agencies worldwide view the TMF as a barometer of study health and compliance with Good Clinical Practice (GCP). For...
Whitepaper: 3 Ways to Fail TMF Inspection
TMF inspections have changed quite a bit in recent years. At the basic level, collaboration, preparation, maintenance, and inspection of the TMF is no longer a centralized effort –...