Articles

What Lies Ahead for Clinical Data Management?

What Lies Ahead for Clinical Data Management?

Collecting, storing and curating the vast quantities of scientific data in existence is not just important for regulatory submissions, but is also vital for ongoing pharma research and clinical trials. Carole L Palmer, a professor of library and information science at the University of Illinois, share her views on the matter and discussed the key issues being overlooked by most organisations

Webinar Summary: Achieving TMF Excellence Through Sponsor and CRO Partnerships

Webinar Summary: Achieving TMF Excellence Through Sponsor and CRO Partnerships

We are delighted to bring you a summary of our webinar on ‘Achieving TMF excellence through Sponsor and CRO partnerships,’ providing practical advice from both perspectives on how to build a transparent, resourceful and mutually beneficial partnership. 

Webinar Speakers: Scott McCulloch, Director of Clinical Quality at InClin Inc. and Vittoria Sparacio, Head of Clinical Documentation at GlaxoSmithKline Pharmaceutical Research and Development


Revolutionising TMF Interoperability: The TMF Exchange Mechanism Standard

Revolutionising TMF Interoperability: The TMF Exchange Mechanism Standard

Ahead of his participation in the Trial Master Files & Inspection Readiness Forum, we spoke exclusively to Paul Fenton, TMF Reference Model Steering Committee member and co-chair of the exchange mechanism standard, about the key benefits of creating a common standard for TMF document exchange. In this interview we discussed with him how the standardised exchange of TMF using the new specification will affect the relationship between sponsors, CROs and the vendors, and how the standard is likely to shape the future of eTMF system exchange.