Whitepaper: Best Practices for End-of-Study TMF Transfer
The Trial Master File is the evidence of your entire clinical trial. When your study ends, it is critical that you have a plan to take control of that data without breaking the audit...
Whitepaper: Maximizing Resources throughout the eTMF Lifecycle
Maximizing resources for emerging sponsors, who are often relying heavily on outsourced partners, can be a challenge.
This whitepaper will cover these key topics:
- The difference...
Whitepaper: How to Conduct a TMF Audit
This whitepaper outlines the process of building and executing your TMF Audit Plan, including:
How to build a TMF Audit Plan / Audit Roadmap
What systems need to be audited (hint:...
Whitepaper: Building IND Regulatory Systems
This whitepaper covers these key topics:
Keeping critical operations in house and outsource commoditized tasks.
Simplifying and improving the hand-off processes to gain...
Whitepaper: How to Partner with Your CRO for End-of-Study Transfer
When sponsors choose to outsource all or certain tasks of a clinical trial to a clinical research organization (CRO), the relationship becomes critical. Since CROs have their own...
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...
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 –...