Pharmaceutical companies have continually faced a growing challenge when it comes to clinical trials. Regulatory authorities have cited these companies as missing required documents in their Trial Master Files and accused them of putting patients and consumers at risk. Failed inspections have led to more frequent visits, large financial penalties, and even revocation of the clinical trial itself. Pharmaceutical companies must find a solution to this problem: a solution that makes their TMF complete, consistent, and compliant.
DIA members have recently recognized this need, formed a SIAC, and set out to create the TMF Reference Model, a manifest of the most common and widely used documents in a Trial Master File. Introduced in February 2011, the Reference Model aims to “provide a single, unified interpretation of the regulations via a document listing which is accepted across the industry.” (Rammell, Eldin, “Rationale for the Model.” Retrieved September 9, 2011 from tmfrefmodel.blogspot.com). While the TMF Reference Model provides organizations with a solid starting point, actual TMF document lists must be modified to fit the individual company’s needs to insure completeness.
Wingspan Technology recently developed a software solution to address the needs of the TMF; moreover, its unique features offer a completely new approach to the Trial Master File. Stay tuned to this blog for more details and information on how Wingspan’s eTMF can make your Trial Master File complete, consistent, and compliant.