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Lagging Technology Adoption and Manual Processes Significantly Impacting Clinical Trial Operations

September 10, 2014

Lagging Technology Adoption and Manual Processes Significantly Impacting Clinical Trial Operations

information-technology-clinical-trials-resolutionsThe data also show that those using advanced eTMF technologies experience greater inspection readiness, visibility, SOP compliance, and cost savings from their eTMF than those using local or cloud file systems.

The use of paper and electronic file systems to manage the TMF contributes to the industry’s continued reliance on manual processes. The survey reveals that email (69%) and paper (57%) remain the predominant means of exchanging trial documents with sponsors/CROs.

The Veeva 2014 Paperless TMF Survey explores the life sciences industry’s progress toward paperless clinical trials by gathering the experiences and opinions of 252 Trial Master File (TMF) owners. The goal of the research is to understand the impact of growing eTMF adoption as well as the drivers, benefits, and barriers to going paperless. The survey examines the success factors for fully electronic trials and gives an industry-wide view of where organizations fall on the spectrum of paper-based to paperless TMFs.

Key Findings

• The types of eTMF s used vary broadly across a range of technologies, from simple file systems to purpose-built eTMF applications.
• More-advanced eTMF systems (content management systems and eTMF applications) deliver a greater number of benefits and higher TMF quality.

Usage of Paper and Types of Electronic Trial Master Files

Respondents were asked to estimate the extent to which different departments manage TMF documents on paper at any time during a document’s lifecycle. Document-focused areas including legal/contracts (53%), clinical operations (43%), clinical records (38%), and regulatory (38%) reportedly manage most/all of their TMF documents on paper at some point during the document’s lifecycle. These paper-heavy departments would benefit most from process-efficiency initiatives.

Conversely, data-driven areas of the business appear to use the least paper. Only 19% of biostatistics, 22% of data management, and 25% of medical science departments are reported managing most/all TMF documents on paper.

Document exchange is another area in which the use of paper-based processes is prevalent. Results show that email (69%) and paper (57%) are the dominant means of exchanging trial documents between sponsors/CROs. Usage is relatively consistent across external parties, with no one party significantly more or less likely to interact via paper or email.

Between sponsor/CRO    With investigator sites        With IRBs/IECs    With reg auth

Paper shipments           57%                                      63%                                       58%                     65%
Email                               69%                                     68%                                       62%                     58%
Portal                              43%                                     37%                                        32%                     30%
Fax                                  25%                                     26%                                        23%                     19%
Cloud file share              30%                                     24%                                        16%                     12%
Content mgmt sys          30%                                     21%                                        18%                     17%
eTMF application           15%                                     10%                                        6%                        8%

Methods for Exchanging TMF Documents with External Parties
A significant fraction of paper TMF documents must be scanned, filed, and reconciled, as the majority of organizations (70%) mostly or always archive TMF documents electronically.

Types of eTMFs
Respondents were also asked which type of eTMF they used most recently. The findings reveal that no one type of eTMF is dominant. The data show adoption of diverse solutions ranging from local file systems all the way to eTMF applications. File systems provide access to a shared folder structure and online storage. Cloud file shares provide additional capabilities, the most important of which is easy access for external parties. An eTMF application is typically built on a content management platform and provides purpose-built functionality and configurations specific to TMF documents, along with process-driven content management functionality such as search, versioning, and workflow.


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