The question of whether existing technologies like eTMF can manage study startup often comes up when I meet with clinical trial sponsors and CROs. There’s a lot of confusion in the market about what these systems can and cannot do, for a few reasons.

First, eTMF and study startup solutions like goBalto Activate serve overlapping user groups but they do so at different stages of clinical trials. eTMF systems focus on the submission and closeout phase of the trials process, whereas study startup focuses on the early stages at the outset of clinical trials.

Second, the terms that are used to describe the separate functions of eTMF and study startup solutions are very similar so their differences become easily muddled.

Lastly, there is some scope creep taking place for which, at first look, eTMF may seem suited. However, when you dig deeper eTMF can’t meet the functional requirements of study startup.

DIA_webinar_clinical_trial_costsThat being said, each system plays an important role in the eClinical stack and in optimizing the full clinical trials process. But pharma companies need to understand that one is not a substitute for the other. So where does one tool’s capabilities end and another’s begin?

Some sponsors and CROs may believe they could rely solely on an eTMF for all documents and to obtain management information about a particular study. However, eTMF systems do not look at end-to-end improvements in clinical trials, especially in study startup. eTMFs have four key limitations that prevent this:

  1. Can’t track critical activities and milestones – While eTMF systems allow study teams to exchange, review, and archive documents, they’re limited to document control, which reflects only 20 percent of startup activities. eTMFs don’t track non-document activities such as submissions, site visits, training, and supplies, which are an important part of the IP release greenlight milestones.
  2. Don’t provide sufficient project management capabilities – eTMFs can’t help you forecast and optimize the resources and business processes required to get documents and other startup activities to the end state. They also cannot facilitate all relevant communications between study teams and sites.
  3. Don’t provide visibility into overall study status and bottlenecks – eTMFs don’t have the complete view of startup status at the site, local, global, and portfolio levels that is needed to facilitate effective partner benchmarking and study team resource allocation. Without a view into all startup activities, eTMFs can’t provide the real-time study status and cycle times required to identify and proactively manage bottlenecks to keep startup activities on track.
  4. Increase audit issues – eTMFs are intended to be the repository for final, approved documents—the source of truth. Using an eTMF to store draft documents, templates, and site communications “dirties up” the eTMF. This leaves an organization vulnerable to having these documents exposed during an audit. Information that was abandoned and not intended to be filed can unnecessarily be exposed to regulatory inspectors.

The process leading to site activation is complex. And eTMF combined with manually maintained spreadsheets, file shares, or homegrown solutions are ill-equipped to facilitate collaboration and manage the complete process. This is especially true on a global basis where the laws, regulations, and hurdles vary tremendously. Purpose-built study startup solutions are needed to fill this void. Study startup applications like goBalto Activate enable sponsors, CROs, and sites to get the first patient signed up in the shortest time possible. These applications support communication, reporting, tracking, oversight, and data management to speed study teams through activation.

Accelerating study startup sets the stage for efficient progress across the entire lifecycle. These study startup applications also integrate with other eClinical tools including eTMF and CTMS to help companies optimize the full clinical trial process. That’s why 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 clinical trial jigsaw.

eClinicalSystems_whitepaper_gobaltoWondering how these systems work together? Don’t worry, you’re not alone. Download 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.