Many CROs Still Using Paper-Based Methods To Share TMF Documentation, Study Finds
By Cyndi Root
A new study by Veeva shows that many contract research organizations (CROs) are still using paper-based trial master file (TMF) documents. According to the survey of CROs, 65 percent use paper in contrast to 52 percent of drug sponsors who use paper. Veeva states in a press release that this discrepancy offers an opportunity for CROs to forge a competitive advantage.
The CROs who are using electronic TMF (eTMF) files have more complete files, better quality files, and files that are more readily inspected by regulatory authorities.
Jennifer Goldsmith, VP of Veeva Vault, said, “Life sciences companies today are increasingly looking to their research partners to streamline the clinical trial process and facilitate faster time to market. CROs today have a tremendous opportunity to distinguish themselves as trusted partners by enabling closer collaboration and strategic process improvements.”
Veeva CRO Survey
Veeva states that since CROs contributed to the development and marketing of all of the top 20 best-selling drugs, the survey is noteworthy and signals a “big opportunity.” Veeva’s pharmaceutical CRO survey is titled, “2014 Paperless TMF Survey: The State of CRO TMFs.” The survey shows that 80 percent of CRO respondents use email to share TMFs compared to 64 percent of sponsors who use email to exchange documents.
CROs stand to benefit strategically from eTMF. CROs with electronic files report that document quality increases by 43 percent, and viewing and tracking of documents increases by 61 percent. Adverse events such as missing, misfiled, incomplete, and expired documents decrease in the range of 62 to 76 percent. Collaboration with sponsors, research sites, institutional review boards, ethics committees, and other CROs increases 28 to 49 percent. Respondents to the survey said that secure access was the critical factor for successful collaborations. One executive at a leading CRO said that eTMF builds trust and fosters ongoing relationships.
Remote Access to Trial Master Files Increasing
In another recent study, Veeva surveyed the life science industry and found that eTMF usage is increasing. Of TMF owners, 16 percent were allowing health authorities to remotely access the files, 32 percent plan to allow access in 2015, and 12 percent plan to upgrade their Information Technology (IT) platform to allow remote access.