There has been an increase in the number of clinical trial sponsors that plan to provide auditors with remote access to their electronic trial master file (eTMF), a life sciences industry TMF survey revealed.
More than 32% of TMF owners surveyed in the Veeva 2014 Paperless TMF Survey: An Industry Benchmark report they will grant auditors remote access to their eTMF by early 2015, versus the 16% who provide access today—a jump of 100%. An additional 12% of survey respondents indicate they will give remote access to their eTMF “as soon as they have the technology to support it.”
Veeva Systems is a provider of cloud-based software for the global life sciences industry, headquarters in San Francisco Bay, Calif. Veeva Systems’ TMF survey 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 Good Clinical Practice (GCP) inspection finding to include TMF accessibility and availability.
Other regulatory authorities globally are likely to follow the MHRA’s precedent, increasing scrutiny on TMFs worldwide.
In 2013, 33% of commercial sponsor inspections required extra days due to an incomplete TMF or lack of accessibility. Further, nearly 30% of inspectors in the U.K. refuse to use paper and, instead, 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 has 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. 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. All parties benefit from complete visibility throughout the duration of the trial, plus sponsors always are prepared for remote or on-site inspection with an always-up-to-date TMF. Health authority inspectors can easily be granted entry to a cloud-based eTMF from anywhere in the world.
For 76% of survey respondents with an eTMF application, an integration with their clinical trial management system (CTMS) 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 (EDC) system as key. These types of integrations allow workflows to extend beyond a single technology and create greater visibility into the status and completeness of the TMF.