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Survey Says, Major Changes Underway in Clinical Operations

By Jill Johnston, VP of Vault Clinical, Veeva Systems

Jill Johnston, VP of Vault Clinical, Veeva Systems

Improved inspection-readiness and faster clinical trials driving industry shift.

We break down the latest findings from the Veeva Paperless TMF Survey, the largest industry wide survey that examines how life sciences companies are managing the trial master file (TMF) throughout a clinical trial. The results provide an inside-look at how critical documents are handled and provide a gauge on the efficiency and effectiveness of clinical trials processes today.

"The industry is transitioning away from paper and seeking a competitive advantage through active eTMF processes"

Overall, Veeva’s third annual global reveals a growing disparity between organizations that use advanced eTMF applications and those that do not. Further, it shows that the maturity of TMF processes varies widely from passive TMF management to more advanced, active TMF processes. Passive TMF management is marked by paper-based processes, even if TMF documents are saved in electronic format. These documents are often housed and duplicated in multiple locations so users cannot accurately or reliably track clinical trial progress. When processes, too, are not integrated across functional areas, external partners, and systems, it becomes difficult to gain visibility into clinical study status and track metrics throughout the clinical trial process.

The use of advanced eTMF applications is a hallmark of active TMF management—a growing industry trend in which a single system manages all TMF documents, related information, and processes from start to finish. In an active TMF model, the TMF is maintained in a constant state of inspection readiness because the TMF composition is an automatic result of an executed clinical process. This approach is driving greater efficiencies in clinical operations and ensuring completeness and quality of TMF submissions throughout the trial.

Here are the top four most-often cited benefits of active TMF management with an advanced eTMF solution.

1. Continual inspection readiness and accessibility

Regulators such as the European Medicines Agency and Medicines & Healthcare Products Regulatory Agency (MHRA) expect, at a minimum, that an organization’s TMF accurately reconstructs how a clinical trial was conducted to demonstrate effective sponsor oversight, support decisions made, and comply with Good Clinical Practice (GCP) guidelines. The MHRA also increased the minimum expectation to have the TMF readily available and accessible at all times, and it must be complete. Yet, the MHRA reports that more than one-third of all site inspections in 2014 were delayed due to incomplete or unavailable TMFs.

Active TMF management maintains the TMF in a constant state of inspection readiness and ensures the completeness and quality of submissions throughout the trial. The composition of the eTMF is an automatic result of an executed clinical process. Maturity of TMF processes varies widely from passive TMF management—where TMF documents are simply stored and archived in file systems and other static repositories—to more advanced active TMF management. Advanced eTMF applications manage documents and processes in real-time as the TMF is being generated. As a result, the TMF is in an “active” or constant state of inspection readiness and the completeness and quality of submissions is maintained throughout the trial.

2. Comprehensive trial documentation

Active eTMF management significantly reduces the issue of incomplete or missing documents, a major quality-control frustration for regulatory agencies. Documents are created, reviewed, and acted upon in one system that is accessed by all study partners. There are no version control issues and no time-consuming document reconciliation effort at study close-out.

3. Easy navigation with intuitive user interfaces

Regulatory agencies typically recommend that their inspectors can navigate a sponsor’s eTMF. after no more than one hour of training. A familiar, consumer web-like user interface allows for quick training and simple navigation.

4. Rich insight to improve operational efficiency

Actively managed, purpose-built eTMF systems capture process- and quality-specific data as the trial is being conducted. Real-time reporting and dashboards leverage this information to provide organizations with an in-process view of the trial. Automated TMF workflows replace outdated legacy processes and ensure TMF quality and timeliness.

Active TMF Management in Action

TMF users leveraging advanced eTMF systems and metrics report advantages over those not collecting data. The two biggest include faster study start-up time (20 percent compared to 5 percent) and shortened overall trial time (23 percent compared to 5 percent).

Exom Group, a CRO that combines strong medical, regulatory, and operational expertise with the most disruptive digital technological solutions to improve quality and performance of clinical trials, offers an example of leveraging the power of data provided by an active eTMF environment to smooth the study startup process. “The eTMF enables a quicker and more accurate collection of documents during the pre-study phase,” explains Luigi Visani, CEO, Exom Group. “These can be filed in real time and shared remotely with the relevant parties as required. Additionally, the presence of dashboard reports gives the study manager an ‘at-a-glance’ view of documentation completeness per site.”

“An active eTMF means provides full and secure control of all steps during the approval process, across multiple recipients, saving considerable time overall,” Visani adds. “Even when delays occur due to local bureaucratic complications, the availability of a cloud document management system such as Veeva Vault eTMF can help to more efficiently manage poorly responding clinical sites. Our experience shows that using the eTMF has significantly simplified and accelerated every part of the document management process.”

The Clinical World is Changing– Are You?

The industry is transitioning away from paper and seeking a competitive advantage through active eTMF processes. Since the inaugural 2014 Veeva Paperless TMF Survey, more companies are making the switch. Advanced, cloud-based solutions, in particular, facilitate the migration to a totally paperless clinical environment as they provide access and enable collaboration for multiple stakeholders wherever they are, whenever they need it, throughout the life of the trial. They also offer unique ways to capture and share valuable trial performance data. Over time, data-driven clinical study optimization will result in more efficient trials and faster times to market—so don’t fall behind. Survey says now is the time to make the change.

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