Case Study

Syncing Transparency Processes To Improve Clinical Trial Compliance

Clinical Trial Protocol

Challenge
A global sponsor was employing a combination of emails, spreadsheets and manual processes to manage their clinical trial disclosure activities. Redundant data entry and maintenance activities across disjointed tools were running in parallel in order to populate multiple global registries. In addition, the sponsor’s homegrown system for managing content for their own branded clinical trial transparency site was difficult to use and expensive to maintain. The tools and processes were not scalable and were wasting valuable resources on labor-intensive, manual processes that were put in place to guard against data entry and version control errors.

With 3,100 trial registrations and disclosures to manage, the company looked to TrialScope to help reduce the risk of inaccurate information being presented to the public. Whether through a global registry or through their own website, the sponsor wanted to ensure consistency and compliance of the clinical trial data being made available to the public.

Solution
The TrialScope team partnered with the sponsor team to implement PharmaCM to manage all of the clinical trial disclosure data. The new system and supporting processes automated the tracking of content and enabled global teams to repurpose the same data for global registries and the sponsor site without having to re-enter data. Implementing PharmaCM, a SaaS based solution, also allowed the sponsor team to realize significant savings on maintenance and support by decommissioning the homegrown legacy system.

Over 1300 users around the globe are now accessing centralized global clinical trial information. The use of one system enables better reporting and process transparency, and alerts and notifications warn users of looming deadlines. One source also supports the synching of data across multiple output formats. Workflows and version control enable disclosure professionals to manage the complexities of the dynamic registration and results-reporting processes.

The sponsor is currently implementing the data transparency functionality of PharmaCM to manage the process of responding to external requests for clinical trial data.

Results
The TrialScope team helped the sponsor to transform obsolete data processes, reduce data entry and  maintenance and ensure compliance and consistency across platforms. These improvements yield substantial productivity gains while enabling the sponsor team to efficiently make clinical trial information available to the public in an accurate and timely manner.