Podcast: Running Regulatory and Clinical Operations in an AI world
Artificial intelligence tools are revolutionizing nearly every stage of the drug discovery process, offering substantial potential to reshape the speed and economics of the industry. As the...
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 –...