Industry Survey: Remote eTMF Access To Double In 2015

By Ed Miseta, Chief Editor, Clinical Leader

Veeva Systems continues to dissect and examine the results of its 2014 Paperless TMF Survey: An Industry Benchmark. The industry’s largest TMF survey to date, which examines the current state of eTMF adoption, was compiled using feedback received from 252 TMF owners. According to the report, we can expect to see significant future growth in remote eTMF access.

More than 32% of TMF owners surveyed in the report plan to grant auditors remote access to their eTMF by early 2015. Only 16% of those surveyed grant that access today, representing a jump of 100%.   An additional 12% of survey respondents indicated they will grant remote access to their eTMF as soon as they have the technology available to support it.

Despite the findings, many pharma companies still face challenges in offering remote eTMF access. “Most life sciences companies find it extremely difficult to provide remote access to the eTMF because, traditionally, eTMF systems sit behind a corporate firewall – that’s assuming the sponsor has an electronic TMF and not still using paper-based systems,” says Jennifer Goldsmith, vice president of Veeva Vault for Veeva Systems. “In order to provide remote access, the sponsor must often provision VPNs and/or laptops and then train external partners to use the software. Because these systems are often complex, it can take days for a new user to learn how to navigate the system.”

Goldsmith notes timing can be another hurdle. Today, health authorities are looking more and more for immediate and complete access to the TMF at any point during the trial. Consequently, the eTMF must always be up-to-date and inspection-ready. In the past, it was common practice to only review the TMF at the end of the process, when the archive was complete. “Today’s real-time access presents a multi-part challenge: provide easy access, ensure software usability, and enable continuous visibility,” added Goldsmith.

Regulators Issue New Guidelines

Jennifer Goldsmith, VP of Veeva Vault, Veeva Systems

The findings in the Veeva survey come on the heels of the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) issuing new guidelines on TMF accessibility. The incidence of inaccessible and incomplete sponsor TMFs resulting in inspection delays prompted the MHRA to update its definition of a critical Good Clinical Practice (GCP) inspection finding, which now includes TMF accessibility and availability. According to the Drug Information Association (DIA), 33% of commercial sponsor inspections required extra days in 2013 due to an incomplete TMF or lack of accessibility. In addition, nearly 30% of U.K. inspectors refuse to use paper, instead requiring access to an eTMF. Goldsmith believes other regulatory agencies globally are likely to follow MHRA’s precedent, placing increased scrutiny on TMFs worldwide.

“With the recent MHRA statements on GCPs and a desire to move to in-process TMF tracking and remote inspection, the results from Veeva’s recent study are not surprising,” says Goldsmith. “The survey finds the number of TMF owners that plan to provide remote access will increase 100% in the next year, but even this estimate is likely conservative. The need for remote eTMF access is acute for compliance purposes as well as for ongoing collaboration with sponsors, CROs, and sites.”

CROs Can Create Cost Savings For Sponsors

Forward-looking CROs leveraging advanced cloud eTMF technology achieve even more cost savings (63%) than sponsors (51 %) and higher benefits, according to the same survey. CROs, for example, can collect more metrics and use them more extensively to improve trial processes than most sponsors, creating a huge competitive advantage to CROs. “Ultimately, a cloud-based eTMF gives trial sponsors, CROs and sites direct, ongoing visibility into the TMF – not just access at the end – for a single, always updated source of the truth,” notes Goldsmith.

As R&D outsourcing continues to rise to meet the demands of 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. The State of CRO TMFs subset of the Veeva survey reveals that 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. Finally, CROs surveyed report easier collaboration with sites (45%), other CROs (49%), and institutional review boards and ethics committees (28%).

“Life sciences companies today are increasingly looking to their research partners to streamline the clinical trial process and facilitate faster time to market,” adds Goldsmith. “CROs today have a tremendous opportunity to distinguish themselves as trusted partners by enabling closer collaboration and strategic process improvements.”

The cloud is certainly helping many companies to overcome challenges. According to Goldsmith, the cloud gives pharma a viable solution to the challenges sponsors often face when providing remote eTMF access. “Most importantly, cloud-based eTMFs completely eliminate the access barrier and make it easy to grant immediate and secure TMF access to inspectors and external collaborators like CROs,” she says. “There’s no need for a laptop and VPN token, just a web browser. Secondly, because most cloud solutions are built with modern technology, they often leverage a consumer-web interface so the systems are much easier to use and to learn. An inspector can be trained to use a newer solution in minutes rather than the hours or days that are typical for traditional systems.”

Technology Integration Will Be Key

The survey also found integrating clinical technology is essential to having a complete solution in place. For 76% of survey respondents with an eTMF application, integration with their clinical trial management system (CTMS) was seen as critical to achieving a paperless TMF. This finding seems to indicate that full integration across the clinical ecosystem becomes crucially important as organizations progress along the technology maturity curve. The survey also found 61% of these respondents also cite integration with an electronic data capture (EDC) system as essential, since these types of integrations allow workflows to extend beyond a single technology and create greater visibility into the status and completeness of the TMF.

For more information on the Veeva survey, click here.