A Background in Clinical Research
Hedian is a senior led specialist TMF consultancy whose founders expertise stems from time in clinical research as a Project Director and Clinical Research Associate (CRA), both in sponsor and Contract Research Organization (CRO) environments. Working solely with TMFs during the move from paper to electronic formats, the founder has been part of industry groups including those which helped to shape and release the TMF Reference Model:
Cutting Edge TMF Knowledge
Having previously lead a global TMF team for a CRO, Hedian leadership ensures that the team of TMF experts at Hedian remain up to date. Accordingly, Hedian is a member of CDISC TMF Reference Model and of the Health Sciences Records and Archives Association, taking an active part in both organizations.
CDISC
As a member of CDISC, Hedian is an active member of the CDISC TMF Risk Initiative. Hedian contributed to the resultant White Paper and presented the CDISC TMF Risk Initiative Tool at various conferences. Your feedback on both the paper and the tool are welcomed by CDISC: you can provide your feedback here.
The current TMF Index, CDISC TMF Reference Model v3.3.1, will see a major overhaul as it transforms from a ‘model’ to a ‘standard’. Hedian has played a part in this ongoing transformation volunteering on the CDISC TMF Standard Model V1.0 Triage Committee.
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