eClinical Solutions profile (page 2 of 6) Case study

Business challenge

The client was dealing with multiple vendors providing coding reports with inconsistent formatting and inconsistent feedback of coding reports. There was a need for a technology that could standardize medical coding reports, provide query and issue management, and ensure proper oversight and documentation of oversight for data review completion.

Solution

With elluminate®, the client was able to standardize medical coding report formats, provide verification of data review oversight with the use of audit trail reports, and streamline communication using the issue management functionality, and create enthusiasm for de-risking overall data quality.

Solution

⚫ Developed standardized medical coding reports for MedDRA and WHO Drug across multiple studies and indications

⚫ Developed search strategy criteria for flagging activities

⚫ Created a self-service, centralized location for oversight documentation along with audit trail

Business challenge

The client sponsors numerous clinical trials globally and works with multiple vendors and Contract Research Organizations (CROs). Because multiple sites and various CROs using different data management systems and formats were involved across trials, data management had become complex and they wanted to streamline its clinical trial operations to improve internal resource utilization, reduce trial cycle times, and avoid costly protocol amendments.

Solution

Client connected with eClinical Solutions to leverage the Clinical Data Cloud® for its CDF. The cloud-based SaaS platform had the versatility and power to address all their needs while still being configurable. With the elluminate Clinical Data Cloud platform, they were able to successfully implement the CDF and positively impact the data management, clinical operations, and R&D teams within the organization. The client utilized several products within the elluminate Clinical Data Cloud, including Mapper, Data Central, and Clinical Analytics.

Impact

⚫ Clinical trial cycle time reduction

⚫ Robust data governance, quality, and compliance

⚫ Improved internal resource utilization and collaboration