More Sponsors Give Regulators Access to Trial Master Files

September 23, 2014
Philip Ward

Philip Ward is ACT's European editor, phone +44 1244 538583, philipward1@btconnect.com

Cloud technology is enabling more clinical trial sponsors to meet health authorities' increasing demands for trial master file accessibility and completeness.

Cloud technology is enabling more clinical trial sponsors to meet health authorities’ increasing demands for trial master file (TMF) accessibility and completeness, according to a new survey from Veeva Systems.

More trial sponsors now provide auditors with remote access to their electronic TMF. Over 32% of TMF owners surveyed in the “Veeva 2014 Paperless TMF Survey: An Industry Benchmark” said they will grant auditors remote access to their e-TMF by early 2015, versus the 16% who provide them access today. An additional 12% of respondents indicated they will give remote access to their eTMF as soon as they have the technology to support it.

These findings come just months after the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidelines on TMF accessibility. Repeated inspection delays due to inaccessible and incomplete sponsor TMFs prompted the MHRA to update its definition of a critical GCP inspection finding to include TMF accessibility and availability, noted the authors of the survey. In 2013, 33% of commercial sponsor inspections required extra days due to an incomplete TMF or lack of accessibility, and nearly 30% of inspectors in the U.K. refuse to use paper and require access to an eTMF, according to the Drug Information Association (DIA) 2014 TMF survey.

“The dramatic rise in sponsors planning to provide remote access is not surprising,” said Jennifer Goldsmith, vice president of Veeva Vault. “Mounting regulatory demands around the globe and growing familiarity with web-accessible content have triggered a shift away from paper-based systems to process-driven eTMF solutions. Further, the anytime-anywhere availability of cloud eTMFs, along with their heightened control and visibility, make them a very compelling industry solution.”

Modern cloud technologies provide secure access to the eTMF over the web, enabling sponsors and partners to work together in real time, and collaborators can log in from any device, modify documents, and save them back to the central repository in the cloud for a single source of the truth, she explained.

For 76% of survey respondents with an eTMF application, an integration with their clinical trial management system is seen as critical to achieving a paperless TMF – indicating that full integration across the clinical ecosystem becomes crucially important as organizations progress along the technology maturity curve. Similarly, 61% of these respondents also cite integration with an electronic data capture system as an essential component. These types of integrations allow workflows to extend beyond a single technology and create greater visibility into the status and completeness of the TMF.

Read the full release here.