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Cloud technology enables clinical trial sponsors to meet health authorities' increasing rigor for trial master file accessibility and completeness
The life sciences industry’s largest TMF survey to date reveals an increase in the number of clinical trial sponsors that plan to provide auditors with remote access to their electronic trial master file (eTMF). 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 them 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’ 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. 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.
Other regulatory authorities globally are likely to follow the MHRA’s precedent, increasing scrutiny on TMFs worldwide.
“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 are always prepared for remote or on-site inspection with an always-up-to-date TMF. As important, health authority inspectors can easily be granted entry to a cloud-based eTMF from anywhere in the world.
Study Shows Integrating Clinical Technology is Key to Completeness
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.
“For too long, pharma has isolated various functional areas in their organizations by equipping them with independent systems that don't talk, causing redundancy and impeding visibility. Integrating the eTMF with CTMS and EDC is an obvious integration that brings immediate value. Sponsors can manage documentation throughout the entire clinical trial process and ensure their TMF is always complete and inspection-ready,” added Eldin Rammell, managing director of Rammell Consulting, Ltd.
The Veeva 2014 Paperless TMF Survey: An Industry Benchmark examines the current state of eTMF adoption, as well as the benefits, drivers, and barriers to implementing electronic processes. This research builds upon respected surveys conducted by the DIA TMF Reference Model group by providing additional insight into the remaining sources of paper and the types of eTMFs utilized – with each question providing a different lens to understanding the industry’s journey to a paperless TMF.
The full research report is now available, and for further detail,Veeva executives along with key partners and customers will discuss eTMF adoption and how to improve inspection-readiness at the DIA EDM 2014 meeting in Washington DC, September 22-24, 2014. Veeva will also bring together leaders across the industry at its R&D Summit, October 20-21, 2014, in Philadelphia, PA. For more information, email [email protected].
• For a copy of Veeva 2014 Paperless TMF Survey: An Industry Benchmark executive report, visit http://www.veeva.com/tmf-survey-2014/