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An In-Depth Look: How a Unified Clinical Environment Increases Trial Performance

Over the past 15 years, sponsors and CROs have steadily adopted clinical technologies to meet specific trial needs. As a result, many organizations have ended up with multiple standalone systems for study planning and setup, site identification and activation, clinical trial management, and TMF. In a recent webinar, “Transforming Clinical Trial Operations: The Next Big Step,” 84% of attendees confirmed that they are using either manual trackers or disconnected CTMS and study start-up systems to manage trials.

Using disparate systems to manage today’s complex clinical trials, which involve hundreds of parallel or sequential tasks, can be extremely challenging. A disconnected environment often perpetuates slow and error-prone manual tasks such as an email-based communication or Microsoft Excel trackers reducing the speed and agility of the trial process. Moreover, multiple logins and user interfaces reduce the visibility and control across different trial activities and milestones.

During the webinar, when asked about the challenges of fragmented technologies, the audience responses included complex and inefficient processes (78%), cumbersome user experience (73%), poor collaboration (62%), and lack of visibility (54%).

These findings are consistent with the Veeva 2018 Unified Clinical Operations Survey report in which almost all respondents (99%) reported the need to unify their clinical trial systems and processes to improve efficiencies and collaboration across all stakeholders.

To illustrate how a unified clinical environment drives higher efficiencies, let’s compare the execution of the two most common clinical processes – site selection and site activation – with disparate systems versus a unified approach. For site selection, a disconnected environment may involve a total of 35 steps and six different systems across site identification and measuring site performance; a unified approach reduces 17 steps and three systems delivering 40% higher efficiencies (see Figure 1). In a typical site selection process, this can translate to a time saving of more than a month.


Figure 1: Site Selection Process in a Disconnected versus Unified Environment

Similarly, a unified approach automates workflows and reporting to make the site greenlighting and initiation process up to 45% more efficient. (Watch the webinar recording for an in-depth comparison and the complete insight on how a unified approach streamlines these processes.)

Just as in the above two examples, a unified approach automates and streamlines all processes in a clinical trial delivering speed and efficiencies. By unifying clinical trial operations, organizations gain full transparency into trial activities from study planning to closure. Sponsors, CROs, and sites use a single source of truth, simplifying collaboration and accelerating study execution.

At Veeva, we believe that the next big step towards transforming the clinical trial operations is to give the industry the best of both words – a suite of best-of-breed applications such as CTMS, eTMF, and study start-up in one cloud platform.