Veeva Systems has introduced the Veeva TMF Maturity Model, a complimentary consultative service designed to assess the state of a life sciences organization’s trial master file (TMF) strategy and provide a roadmap for improvement. The Veeva TMF Maturity Model gives practical, step-by-step guidance to help companies transform their TMF from a static archive into a strategic asset that can help increase the efficiency of clinical trials. It is available as a self-service online tool or as a more detailed, in-person evaluation with a seasoned subject matter expert.
The Veeva TMF Maturity Model assessment provides companies with a tailored report, outlining the current state of their TMF, comparison to industry benchmarks, and a roadmap for improvement. More than 60 life sciences companies have already completed the evaluation.
Data amassed to date shows companies who have completed the Veeva TMF Maturity Model evaluation are only halfway along the full TMF maturity curve, averaging 2.54 on a scale of one to five. These empirical findings are consistent with industry-wide survey data from the annual Veeva 2015 Paperless TMF Survey showing an industry shift away from maintaining paper documentation; however, there is still too much reliance on manual processes. More than half of survey respondents (59%) report archiving documents electronically, yet far fewer have fully digitized other key activities such as e-signatures (21%), document creation (25%) and collaboration (30%).
“In just one year, the industry has seen a dramatic uptick in electronic TMF application adoption,” said Jason Methia, director of Vault eTMF strategy at Veeva. “The Veeva TMF Maturity Model provides the industry with a reliable framework to make systematic strides towards shedding paper and transitioning toward automated methods and systems.”