Situation:
The clinical division of a large medical device company with 10+ global locations and 50+ active clinical trials chartered an enterprise-wide systems initiative to automate and optimize processes for data collection/management, safety event processing, site selection/monitoring and trial master file management.
Solutions:
- A gap analysis was conducted of the existing manual processes and workflows through a series of interviews, process mapping and document analysis.
- Optimized workflow for each major process was built with the functional teams, followed by the development of business requirements for systems to provide global, scalable, auditable solutions
- The business requirements were used to develop a vendor selection process, identify possible solutions and obtain budget approval for the project.
Value:
The systems initiative resulted in a phased implementation of revised workflows and supporting systems. Over the course of 3 years, global staffing levels were reduced, internal audit results improved and previous process bottlenecks were resolved. Annual operating budgets were reduced and employee satisfaction and retention increased.