Over the last 12 months we have seen a significant rise in the number of clinical trial sponsors and contract research organisations who are considering a move away from paper-based trial master files. The publication of the DIA TMF Reference Model has also stimulated interest in this topic.
However, migration towards managing electronic trial documents is fraught with potential difficulties. We can provide support in the planning 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. In addition, we also provide customised eTMF workshops which can be delivered either as a standalone service or as part of a larger consultancy contract.
