Clinical Data Warehouse Assessment for a Biotechnology Company

The client, a commercial biopharmaceutical company, has rapidly expanded the number of clinical trials it was conducting to over 180 clinical trials, across therapeutic areas, in various sites across the globe. To support their clinical operational reporting needs, they have been using a packaged solution from Oracle which addressed some out-of-the-box needs. Due to pain points in their existing reporting, the client began to move away from predominately using Oracle applications to using applications from other clinical vendors such as Veeva (Veeva CDMS and Veeva Study Startup) and Medidata Rave’s EDC solution.

Challenges

Due to this change in applications, the business felt like they had reached an inflexion point: should they continue to expand their existing reporting and analytics environment, look at other solutions, or develop a custom solution? The client wanted an independent assessment of their reporting and analytics environment to understand what opportunities exist to improve the efficiency and effectiveness of its operations, as well as its ability to address both current and future business needs and direction.  

Triverus successfully delivered an assessment of the current environment and its capabilities, identified challenges and gaps across people, process and technology, and provided a high-level roadmap of initiatives to address them.

Despite significant functional challenges, the existing Oracle based application provided valuable reporting and analytics.  The client wanted to continue to leverage this environment for as long as possible to reduce the disruption to the business by replacing Oracle.

Results

The Triverus team worked with the biotechnology company to assess the existing clinical reporting and analytics environment and create an actionable Roadmap to get from where it is now, to where it needed to be, in a phased approach over time. The assessment and subsequent initiatives and recommendations were focused around three areas – people, process and technology. The series of initiatives that Triverus laid out, enabled the client to continue to leverage its existing environment and make changes while increasing the effectiveness and quality of the information it provides to the business.

How We Helped

To execute its proven assessment methodology, Triverus brought a team of experienced Life Science subject matter experts to conduct the assessment and develop the roadmap.  Over the course of this twelve-week engagement, the Triverus team met with business leadership across Portfolio and Capacity Management, Clinical Supply Chain, Development Project Management, Clinical Operations, Medical Writing, Biostatistics, Data Management, Clinical Trial Disclosure, Global Clinical Monitoring and Development IT groups to determine the needs of the organization and define an actionable roadmap.