Leading Academic Clinical Research Organization
Empowering Strategic and Informed Clinical IT Decisions
Our client is an academic clinical research organization (CRO) that offers services across the entire clinical research spectrum, from study conception to design, execution, data analysis, and the dissemination of results.
Identifying the Right Clinical Data and Trial Management Systems
Our client has been leveraging its legacy clinical data and trial management systems for many years. The CRO had become frustrated with the clinical data management system's lack of functionality, specifically the inability to produce custom metrics and reports quickly. By the time reports could be pulled, the data was often outdated.
The clinical data management system had also ceased to be its vendor's flagship data management solution, not to mention that newer systems on the market appeared to be more advanced.
Furthermore, our client was using a version of its clinical trial management system that was no longer supported and considered to be significantly behind newer releases and other CTMS solutions on the market. Since the company's system was highly customized, patching and upgrading had been cost prohibitive.
In addition to the challenges our client had experienced with these systems, they were also not integrated. This required the organization to manually enter data in both systems, and it was often the same data.
Creating a Path to Operational Efficiency
Our client knew of our experience with clinical data and trial management systems, including detailed knowledge of the two systems it already had installed. Coupled with our strategic advisory services, this made us the ideal partner to support strategy and roadmap development that would help determine whether the company should move to new solutions and, if so, which ones it should consider.
Our plan provided concrete recommendations on how to proceed with the implementation of new systems, decommissioning of legacy systems, and what to do with the data housed in the existing systems.
Our services included:
- Defining business goals and objectives
- Conducting stakeholder interviews
- Evaluating the current state
- Defining the desired future state
- Requirements gathering
- System and vendor evaluations
- Systems selection/implementation strategy and roadmap
- Legacy systems decommissioning strategy and roadmap
The CRO is empowered to make strategic and informed business decisions that will benefit the company for years to come.
Results
Ensuring Compliance Health
The gap analysis identified that approximately 30% of our client’s IT systems were being used for regulated activities, and therefore needed to meet the defined requirements related to GxP, 21 CFR Part 11, Annex 11, HIPAA, and/or privacy regulations.
It was also determined that our client’s system development lifecycle required some modifications in order to be fully compliant with the regulations. There were also gaps identified in some of the validation deliverables.
With a thorough compliance review of IT systems complete,and recommendations for closing the gaps having been provided, our client now better understands what actions it needs to take in order to become completely compliant with specific industry regulations.
