DIA 2016

Survey: paperless TMF advantages and progress

By Melissa Fassbender contact

- Last updated on GMT

(Image: iStock)
(Image: iStock)

Related tags: Better

According to a recent survey, there are significant advantages to adopting eTMF – although some challenges still remain in the shift towards paperless clinical trials.

Veeva will be presenting the full results of its the Veeva 2016 Paperless TMF Survey: Annual Report​ at the DIA 2016 Annual Meeting on Tuesday, June 28 at 3:25pm in the Innovation Theater, Exhibit Hall B.

There is a rapid change underway in clinical development​,” Jennifer Goldsmith, Senior Vice President of Veeva Vault at Veeva Systems, told Outsourcing-Pharma.com, who added that eTMF has become an integral component of daily clinical operations.

When documents are created, reviewed, and acted upon in one system by all parties it provides full visibility and enormous operational efficiencies​,” she added. “Organizations that use the most advanced eTMF technologies are already expanding the scope of its use to not only help execute critical TMF activities, but to plan and manage their overall clinical development strategy​,” and Goldsmith expects this trend to continue.  


According to the survey, eTMF application adoption has doubled among sponsor respondents with one in four (24%) now using an eTMF application. Those respondents report significant improvements in inspection readiness (61%), improved central and remote monitoring (59%), and better visibility into performance metrics (55%).

eTMF adoption is also changing the nature of collaboration as sponsors move away from closed systems and bring more CROs, sites, and other partners into their eTMF​,” Goldsmith said.

For example, a quarter (24%) of sponsors now use their eTMF application to collaborate with CROs (up from 14% in 2014), and 17% work with their sites in their eTMF application (up from 11% in 2014). Additionally, 80% of those using an eTMF application are granting remote access to auditors and inspectors.

The findings underscore a need to unify and streamline clinical processes (almost half of sponsors cite the need to integrate CTMS and/or EDC with eTMF), bring parties together, and uncover new efficiencies,​” explained Goldsmith.


The most surprising finding is that despite the compelling evidence of the benefits of leveraging metrics to improve clinical operations, the industry has barely moved the dial on collecting and using metrics​,” said Goldsmith.

Specifically, the same number of respondents who are extensively leveraging metrics (18%) aren’t collecting data at all – and a large majority (65%) only use it sporadically.

The advantages of that type of insight is invaluable​,” said Goldsmith, who added that those respondents extensively leveraging metrics cited large improvements over those not collecting data.

These improvements include, improved audit and inspection readiness (67% to 29%), better visibility into performance metrics (53% to 14%), cost savings (47% to 10%), shortened clinical time (23% to 5%), and faster study startup (20% to 5%).


Goldsmith explained that the industry has made great progress toward paperless trials. For example, clinical operations departments, which are the largest contributor to the TMF, have cut the number of TMF documents they manage on paper nearly in half over the last three years – from 43% of most to all documents on paper in 2014 to 25% today.

More documents are also being exchanged via eTMF applications​,” added Goldsmith. Specifically, a quarter (24%) of sponsors now use eTMF applications to collaborate with CROs (up from 14% in 2014), and 17% work with their sites in their eTMF application (up from 11% in 2014).

However, closed systems like email not only continue to persist but thrive with approximately 70% of respondents report using an email to exchange TMF documents​,” explained Goldsmith.

Similarity, many processes remain manual despite eTMF technology adoption. For example, according to the report, only 22% of sponsors leverage eSignature despite acceptance by regulatory agencies.

When processes and technology are not integrated it causes manual and duplicative work that negates the efficiencies gained by adopting an eTMF​,” added Golfdmith.


According to Goldsmith, many expect a move to an end-to-end eTMF application will improve inspection readiness (63%), speed study startup (52%), and help gain visibility into performance (43%).

She added that “These expected benefits are consistent with actual results from those using an eTMF application,” ​who report improved audit and inspection readiness (61%), improved central and remote monitoring (59%), and better visibility into performance metrics (55%). However Goldsmith said that the advantages of fully paperless trials extend “well beyond that​.”

As paper is removed from the process, systems that once were siloed can now integrate and create a more unified view of clinical operations and study status​,” explained Goldsmith. “Better decisions can be made and cycle times dramatically shortened, all leading to safe and effective drugs getting to patients faster​.”

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