A new survey by Veeva Systems has revealed that more clinical trial sponsors are planning to make their electronic trial master files (eTMFs) remotely accessible.
"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."
The TMF is a collection of certain documents that clinical trial sponsors must maintain in order to comply with regulatory agencies. The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has revised its guidelines after incomplete or inaccessible TMFs have caused repeated inspection delays. The MHRA estimates that 33 percent of clinical trial inspections have been delayed due to problems with the TMF. Another 30 percent of inspectors refused to use paper documents.
Veeva Systems wrote up its findings in a new report titled “Veeva 2014 Paperless TMF Survey: An Industry Benchmark.”
One solution is to use an eTMF, using computer files and making them accessible to inspectors outside of the organization. Researchers can also log in and modify their documents from a central place on any device. According to Veeva’s survey, 32 percent of TMF owners planned to offer remote access by 2015, a 100 percent jump over the previous year.
Veeva also found that 76 percent of the respondents with an eTMF application saw integration with a clinical trial management system (CTMS) as a way to achieve a paperless system. Another 61 percent wanted to integrate with an electronic data capture system (EDC) to make things even easier for themselves and regulators.
“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,” Eldin Rammell, managing director of Rammell Consulting, said. “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.”