The vast majority of CROs surveyed lag behind sponsors in how they exchange trial master file (TMF) documents, according to a Veeva Systems survey, Veeva 2014 Paperless TMF Survey: The State of CRO TMFs.
Veeva Systems, a Pleasanton, Calif.-based provider of cloud-based software for the global life sciences industry, found 80% of CRO respondents report using email and 65% still rely upon paper-based methods to share TMF documentation, whereas a smaller number of sponsors exchange TMF documents via email (64%) and paper (52%).
This new research details CROs’ progress in moving toward paperless trials and revealed opportunities for managing and maintaining inspection-ready TMFs on behalf of sponsors. The data showed those CROs leveraging eTMFs have higher quality and more complete trial master files, noteworthy in a market in which CROs contributed to the development of all 20 of the top-selling drugs in 2013.
The survey also found CROs achieve important strategic advantages when utilizing an eTMF. For example, many CROs report improvements in real-time tracking and viewing of documents (61%), and increased document quality (43%). CROs also see improvements in multiple inspection areas, including reduction of missing (76%), misfiled (76%), duplicate (72%), incomplete (65%) and expired (62%) documents.
R&D outsourcing continues to rise sharply to meet the demands of life sciences organizations’ growing pipelines. CROs that operate more efficiently and collaboratively will be better able to partner with sponsors in delivering new and innovative drugs and therapies.
“Life sciences companies today are increasingly looking to their research partners to streamline the clinical trial process and facilitate faster time to market,” said Jennifer Goldsmith, vice president of Veeva Vault. “CROs today have a tremendous opportunity to distinguish themselves as trusted partners by enabling closer collaboration and strategic process improvements.”
Collaboration with external partners is another area in which CROs are effectively leveraging eTMFs. CROs surveyed report easier collaboration with sites (45%), other CROs (49%) and institutional review boards and ethics committees (28%). Given the importance of collaboration, 67% of CROs cite secure access for external parties as a key eTMF requirement.
The survey showed advanced eTMF solutions, in particular, deliver greater visibility, inspection readiness, SOP compliance and cost savings over local or cloud file systems. Process-driven functionality and easy, secure cloud access to the eTMF, enables CROs, sponsors, investigator sites and other partners to more effectively and efficiently work together. All parties benefit from greater visibility throughout the trial, plus sponsors are better prepared for remote or on-site inspection. And health authority inspectors are easily granted access to an eTMF in the cloud without elaborate training or complicated provisioning.
“Increasing demand from U.S. and European health authorities for direct access to TMF documents indicates a growing trend—a move toward in-process inspections by regulatory bodies globally,” said Goldsmith. “The highly accessible nature of the cloud supports this need by allowing all collaborators to upload and access documents in real-time rather than having to go back and reconcile the entire TMF at study close-out.”
The top drivers of eTMF adoption among CROs surveyed are cost savings (63%) and speeding study start-up (59%). Some CROs perceive regulatory requirements for wet ink signatures (40%) and institutional review boards and ethics committees’ demands (34%) as major/insurmountable barriers to eTMF adoption. These perceptions, however, likely are based on dated notions since all major health authorities now accept electronic signatures. These perceived barriers are out of step with sponsors as well, who are less likely to see regulatory or IRB/IEC requirements as barriers. Only 19% of sponsors report regulatory requirements as a major/insurmountable barrier and only 9% cite IRB/IEC requirements.