Clinical Trial Document Management System_Case Study in a Biopharmaceutical Company

Agatha achieves in-house production with eTMF! The system can be configured according to operational methods.

We would like to introduce a case study of "Agatha eTMF" by InCarda Therapeutics, which conducts clinical development in California, USA. The company had outsourced TMF management, but it became increasingly complicated, and it was clear that a more rational and cost-effective operational method was needed. The implementation project was completed in about six weeks and included various configuration changes, document classification definitions, the addition of new fields such as responsible persons and affiliations through an automatic naming function, and user training. [Case Overview] ■ Challenges - Difficulty in document verification, requiring manual tracking for quality checks - Need to directly check TMF documents whenever an issue arose ■ Benefits - Ability to configure the system according to operational methods - Automatic verification of all documents within the system without relying on manual processes *For more details, please download the PDF or feel free to contact us.

Document and Data Management