June 16, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
A new survey from cloud-based software giant Veeva has found the global life sciences industry is using less paper in its daily business operations than ever before, an executive told BioSpace Tuesday. The Veeva 2015 Paperless TMF survey recently found a striking reduction in the amount of paper used by clinical operations, from nearly half of respondents in 2014 down to 31 percent today.
That had BioSpace asking the question: Is it possible that the life sciences and biotech industries could be completely paperless anytime soon? We chatted with Jennifer Goldsmith, vice president of Veeva Vault, who said that this industry in particular can benefit from going paperless.
“A typical Phase III study can generate 500 parcel shipments, 10,000 documents and 80,000 pages,” said Goldsmith. But that doesn’t have to be the case, she said.
“As more life sciences organizations continue to transition away from paper and paper-based clinical processes in favor of electronic methods of document exchange and purpose-built eTMF solutions, they will naturally begin to capture more and richer data about clinical trial processes,” said Goldsmith.
“This is the apex of major change in the industry because more data and insights from that data will ultimately lead to significant improvements in clinical efficiency and quality at a faster rate,” she added. “Rather than making incremental process improvements over years, life sciences companies will then be empowered to take big leaps forward to bring more valuable medicines to market faster.”
Goldsmith’s company is in a position to know what’s possible. Veeva Systems is a public company with more than 1,000 employees worldwide, supporting at least 275 life sciences companies, including 33 of the top 50 largest pharmaceutical companies in the world. Moreover, Veeva has more than 50 Veeva Vault eTMF customers, including five of the top 20 global pharmaceutical companies and four of the leading contract research organizations.
She said the takeaways from the Veeva 2015 Paperless TMF survey were pretty striking:
Paper is being removed from key functional areas, such as clinical operations, and more electronic processes are being utilized.
•Nearly half (43 percent) of respondents reporting most or all TMF documents in Clinical Operations being managed on paper in 2014 down to one-third (31 percent) in 2015
eTMF applications have a significant impact on improving inspection-readiness.
•61 percent of respondents that use an eTMF application report improved inspection-readiness as a benefit.
Remote access will be a key requirement for inspection-readiness.
•A quarter of respondents currently grant remote access to the TMF, and 65 percent expect to do so by early 2017.
•57 percent of respondents that use an eTMF application currently grant remote TMF access to auditors and inspectors.
Organizations that use metrics derive more benefit from their eTMF, but the industry is still slow in collecting and leveraging metrics to improve trial processes.
•Only 14 percent of respondents are extensively using TMF metrics to improve trial processes.
•82 percent of respondents that extensively leverage TMF metrics report improved audit and inspection readiness, versus only 25% of those that do not collect metrics
The survey polled 186 total respondents 65 percent of whom were sponsors; 20 percent CRO and 15 percent consultants. About 65 percent of those were American, while the rest were from international corporations.