Life Science Industry Increasing Remote Access To Trial Master Files
By Cyndi Root
A life science industry survey by Veeva Systems reveals that remote access to Trial Master Files (TMF) is increasing. The survey, announced in a press release, states that 16 percent of TMF owners are currently allowing health authorities remote access to their eTMF. However, 32 percent plan to allow remote access in 2015. Cloud technology, which allows files to reside on remote servers for auditors to access, is the primary driver of the trend. The survey says that another 12 percent of respondents will allow access when they have the Information Technology (IT) assets to support the effort.
Jennifer Goldsmith, VP of Veeva Vault, said, “The dramatic rise in sponsors planning to provide remote access is not surprising. 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.”
Veeva Survey
Veeva’s report titled, “2014 Paperless TMF Survey,” shows a growing trend in the U.S. of health inspectors accessing electronic TMF (eTMF) files remotely. Ms. Goldman said that eTMF and cloud services appeal to the pharmaceutical industry due to the “anytime-anywhere availability.” She said that regulators are increasing their demands for rigorous reporting, including accessibility and control. These benefits make eTMF and cloud services compelling to industry.
eTMF Regulations
As industry embraces the technology because it helps them comply with regulations, regulators are moving in to guide the technology. The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) announced new guidelines on TMF accessibility in April 2014. The agency stated that repeated inspection delays due to inaccessible and incomplete sponsor TMFs is not compliant with Good Clinical Practices (GCPs). The agency notes that in 2013, about 33 percent of inspections were delayed due to the lack of TMF accessibility or TMF incompleteness. Many inspectors in the U.K. (30 percent) actually refuse to use paper, preferring the eTMF instead.
Veeva states that MHRA’s move will have an effect on the global trial environment and other agencies will likely follow the precedent. eTMF allows real-time collaboration and modification of documents that are saved in a central repository. The Veeva survey also revealed that an integrated eTMF is preferred — one that syncs with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.