Survey Reveals That Remote eTMF Will Double In 2015
By Megan Williams, contributing writer
The survey “Veeva 2014 Paperless TMF Survey: An Industry Benchmark”, the largest TMF (trial master file) survey in the industry, has revealed an expected dramatic increase (to 32 percent) in access to electronic trial master file (eTMF) provided to auditors by clinical trial sponsors in 2015. Currently, only 16 percent provide remote access to their eTMF. Solutions providers may find some opportunity in the additional 12 percent of respondents who indicated they will provide remote access once they have the necessary supporting technology.
This announcement comes on the heels of the U.K.’s Medicines And Healthcare Products Regulatory Agency (MHRA) announcing new guidelines on TMF accessibility. Previously, the industry had seen repeated inspection delays because of inaccessible and incomplete sponsor TMFs, prompting the MHRA to update what defines good clinical practice (GCP). This is relevant in the U.S. market because other regulatory authorities are likely to follow suit, and increase their scrutiny on TMFs here.
“The dramatic rise in sponsors planning to provide remote access is not surprising,” Jennifer Goldsmith, vice president of Veeva Vault is quoted as stating. “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.”
Integration Of Clinical Technology
According to the survey, 76 percent of respondents with an eTMF application viewed integration with their clinical trial management system (CTMS) as critical to crossing the bridge to a fully electronic TMF. This need will be common to any organization looking to bring their technology infrastructure and offerings to a more mature level. The majority of respondents (61 percent) also indicated that integration with an electronic data capture (EDC) system, was key to their maturation process
All of these numbers indicate a desire in the pharma sector to better integrate their processes.
“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” said Eldin Rammell, managing director of Rammell Consulting, Ltd.
“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.”
A full copy of the survey can be requested here.