Daniel has worked in various TMF roles for large pharma companies and small biotech, with a full-service CRO and a niche TMF provider. Having seen the issues from all sides he is a convert to the idea that the TMF is a key part of a quality approach to clinical trial management. He was very involved with the development of version 3.2 of the DIA TMF Reference Model and is excited to see how companies make use of the changes to deliver better quality TMFs and better oversight.