Before we answer this question, let’s just state for the record: an eTMF is an important tool for organizing your clinical study startup documents and providing easy access to those documents. An eTMF plays a central role in the submission and closeout phase of the trials process. One in five CROs is currently using an eTMF application, while about 44 percent of sponsors are doing so1.

Still, an eTMF is ill-equipped to bring end-to-end improvements to your clinical trials, especially in the early stages of study startup. There are four important shortcomings an eTMF has in supporting and optimizing study startup. In my last post, I outlined these limitations in detail but here’s a quick recap:

  • eTMF can’t track critical activities and milestones; it’s limited to document control
  • eTMF can’t help optimize resources and business processes required to get documents and other startup activities to the end state
  • eTMF has poor visibility into study status and bottlenecks
  • Using eTMF to store draft documents, templates and site communications increases audit risk

Purpose-built study startup solutions fill this void and sponsors and CROs are adding study startup applications like goBalto Activate to the eClinical stack. Let’s look at how goBalto Activate fits in.

“Smart” country-specific workflows guide the work and help standardize global processes

Activate standardizes processes and guides study teams to complete and track the specific documents and tasks required for any site, country, or study based on your SOPs or internal processes. With Activate, you receive alerts and notifications that tell you what to do next. An eTMF doesn’t have the level of country intelligence and functionality that Activate provides out of the box.

Enhanced metrics and reporting

Activate provides real-time reports that help you easily identify and resolve bottlenecks. Any time a study team member completes an activity, it’s automatically tracked. Conduct a cross-study analysis and easily customize reports to display just the data you want using a variety of visualizations, such as bar and line charts.

Seamless integration

Activate is not an eTMF; however, it easily integrates with one. Your eTMF is for completed documents. Activate is the repository for in-progress documents. Activate’s integration toolkit can be used to automatically transfer completed documents to yours and your partner’s eTMF, organized neatly into TMF reference model folders.

Review for completeness

Activate allows you to ensure your documents are reviewed and approved, including after IP release. Activate ensures that all documents are reviewed and completed by the right people, and that everything is accurate, complete, and audit-ready.

Business Process Management – increased productivity

Activate gives you visibility into all the steps of your business process, making it easier to map your current processes and identify no-value-added (NVA) steps. Once your processes become more transparent, you can eliminate unnecessary steps—such as extraneous communication, emails, and metrics gathering—for true, continued process improvement.

Today pharmaceutical companies have access to a variety of cloud-based technologies that can radically improve the clinical trials process. These eClinical tools need to be assessed as part of the overall picture of clinical study management, rather than just looking at one piece of the puzzle.

Want to learn more?

eClinicalSystems_whitepaper_gobaltoDownload our white paper Using eClinical systems to speed up clinical trials for a deep dive into the roles of eTMF, CTMS and study startup solutions in the clinical trials process.

[1] TMF Reference Model: Topline Results of 2014 TMF Survey #4, Fran Ross, August 2014

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