Webinar: Inspection Preparedness after TMF Transfer from your CRO
This webinar discusses inspection preparedness for a TMF inspection, with a particular focus on virtual and hybrid inspections.
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:...
SharePoint vs RIM: When to migrate to a Compliant RIM System
Are you a regulatory leader trying to meet tight submission deadlines with distributed teams and multiple vendors responsible for various content? You are not alone. Many sponsors are...
How to Choose an EDMS for Regulatory Information Management
In pharma and biotech, managing regulatory information effectively is crucial for compliance and success. An Electronic Document Management System (EDMS) provides a powerful solution to...
Conducting a TMF Audit for Inspection Preparedness
Conducting a Trial Master File (TMF) audit is an important aspect of maintaining the quality and integrity of clinical trial data, as well as preparing for inspections. In this article, we...
Considerations for moving an electronic clinical trial
Moving an electronic Trial Master File (eTMF) can be a complex process that requires careful planning, coordination, and execution. A TMF is a collection of essential documents that...
Webinar: Best Practices for End of Study TMF Transfer
Do you have a plan for receiving your TMF from your CRO soon? Have you mapped out your strategy and how you will ensure you are maintaining the chain of custody for what is one of...
Best Practices for End of Study TMF Transfer
In the context of clinical trials, the end of study transfer is a crucial process that involves the transfer of various study-related documents, data, and materials from the sponsor or...
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...
CTIS Part III: Adapting Your Organization to CTR/CTIS requirements
With CTIS now mandatory, it is imperative for sponsors planning a clinical trial submission in the EU to take all the necessary steps to maintain CTR compliance. Now is the time to make...
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...
CTIS Part II: Document Management Best Practices for CTR Compliance
As highlighted in our previous blog, sponsors submitting trials in the EU will have to adopt a more integrated and collaborative workflow to meet the new submission requirements of EU...