The State of CRO TMFs: Beginning a Journey Toward Paperless Trials
R&D outsourcing continues to rise sharply to meet the demands of life sciences organizations’ growing pipelines – in fact, CROs contributed the development of all the top 20 drugs in 2013. [1] As the marketplace rapidly expands, CROs that operate more efficiently and collaboratively will be able to offer a more competitive level of service as trusted partners.
In the light of these changes to the clinical landscape, the Veeva 2014 Paperless TMF Survey – the largest survey of its kind to date – measures the industry’s progress toward a fully electronic trial. A new report, the Veeva 2014 Paperless TMF Survey: The State of CRO TMFs, examines eTMF adoption among contract research organizations (CROs) and sponsors in order to understand the similarities and differences as they both journey toward the paperless study. The survey reveals tremendous opportunity for CROs to transform the level of service they provide by better managing TMF documents.
Progressive CROs leveraging advanced eTMF technology see crucial strategic advantages, the survey reveals. 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. Working effectively with external partners is another area where CROs with eTMFs are benefiting: they report easier collaboration with sites (45%), other CROs (49%), and institutional review boards and ethics committees (28%).
Yet, despite these gains, CROs are actually using eTMF technology at a lower rate than sponsors are – revealing a clear avenue for forward-looking CROs to distinguish themselves. Eight in 10 (80%) CRO respondents currently report using email to share TMF documentation and 65% still rely upon paper-based methods, lagging behind sponsors.
Industry trends also indicate the growing importance of leveraging modern technology in the clinical space. The full findings from the Veeva 2014 Paperless TMF Survey were released on the heels of new regulations from the MHRA requiring remote access to trial master files – at any time during the trial. In 2013, 33% of commercial sponsor inspections required extra days due to an incomplete TMF or lack of accessibility. Moreover, nearly 30% of inspectors in the U.K. refuse to use paper and, instead, require access to an eTMF, according to the Drug Information Association (DIA) 2014 TMF survey. Remote eTMF access for auditors among sponsors is set to double in 2015, Veeva 2014 Paperless TMF Survey findings show – an important development as global scrutiny increases.
“The dramatic rise in sponsors planning to provide remote access is not surprising,” says Jennifer Goldsmith, vice president of Veeva Vault. “Mounting regulatory demands around the globe and growing familiarity with web-accessible content has triggered a shift away from paper-based systems to process-driven eTMF solutions. Further, the anytime-anywhere availability of cloud eTMFs, along with their heightened control and visibility, make them a very compelling industry solution.”
For more key findings from the Veeva 2014 Paperless TMF Survey: The State of CRO TMFs, read the full report.
[1] Association of Clinical Research Organizations, Survey Shows Strong CRO Growth, September 16, 2014. http://www.acrohealth.org/acro-survey-shows-strong-growth-cro-industry/