CTMS vs eTMF: What Is the Difference?

Conceptual illustration showing a CTMS as a short operational span nested inside a much longer eTMF span that continues for 25 years after the trial concludes

A CTMS runs a clinical trial while it is happening. An eTMF holds the evidence that it happened that way, for 25 years after the trial concludes under the amended UK regulations. This guide compares the two on retention, structure and inspection, and gives six questions that route any record to the right system.

What are the 4 Phases of Clinical Trials?

The 4 trial phases

The clinical trial research is divided into four distinct phases, each serving a specific purpose in the pursuit of safe and reliable medicines. These phases constitute a structured journey, guiding investigational products from their initial introduction to thorough evaluation and eventual widespread usage. All of this is effectively planned and executed with the help of […]

5 Tips for a Successful Integration of CTMS with EDC

Integration of CTMS with EDC

Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) systems play crucial roles in the efficient conduct of clinical trials. Integrating these systems can streamline processes, improve data quality, and enhance overall trial management. Here are some tips for successful integration of CTMS with EDC: Define Integration Goals Integration goals are important to specify […]

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Written for first-in-human & Phase 1 sites

Inspection-ready checklists & templates

Aligned to MHRA, FDA & EU Annex 11