Over the last 12 months we have seen a significant rise in the number of clinical trial sponsors, contract research organisations and investigator sites who are considering a move away from paper-based trial master files. The broad adoption of the TMF Reference Model has stimulated interest in this topic as has the publication of the GCP Guide by the MHRA and the focus on TMF in GCP inspections…. particularly how to avoid those critical findings! The question today is not so much whether to implement an eTMF but how you should choose and implement an eTMF.
However, migration towards managing electronic trial documents is fraught with potential difficulties. What type of system should be implemented? Is it acceptable to use a “cloud” solution? What is needed to ensure long-term preservation of electronic records? Are electronic signatures allowed and how should they be implemented? Can we destroy hard-copy records?
These are just a small selection of the questions that we can help you answer. Ensuring the success of your eTMF project is absolutely critical; get the process right, get the technology right, get the quality right. We are happy to involved in your project as much or as little as you need. We can provide support in the planning and implementation of your project to ensure it will meet regulatory and legal requirements and follows sound records management principles. We have worked to assist a number of top-20 pharma companies with implementation of eTMF projects as well as supporting smaller pharmaceutical and biotechnology companies. We have also worked alongside other large consulting firms to provide our experience and subject matter expertise. In addition, if you just need to improve your knowledge of TMF-related requirements and issues, we also provide standard or customised eTMF workshops which can be delivered either as a standalone service or as part of a larger consultancy contract.