The clients clinical trails were disorganized and audits were very cumbersome and inefficient. They also had an aging Document Management System they were using as their Trial Master File (TMF). The system had never been designed or implemented to manage trials and support inspection readiness.
Corporate IT, Trial Managers and Executives all had different ideas of how to move forward and no clear direction, roadmap or organized approach as to how, when or what needed to be done across the organization to solve the issues.
The Verista APO team was deployed and accomplished these goals:
Maintenance Roadmaps: Developed maintenance schedule for the existing Document Management System, including resourcing and costs, a 6-quarter roadmap and five-year horizon.
Total Cost of Ownership View: Defined all support labor costs associated with the application, determined all infrastructure costs, software licensing and total “run” costs.
Engagement & Communications Documented and held monthly senior level updates. Conducted regular 1:1 meetings with all key business partners and ensured Business Partner & Stakeholder felt informed, that communication was proactive and business priorities were being set inline with business needs.
Documents managed in real-time. eTMF generated to ensure a constant state of inspection readiness, increase visibility and oversight.
Significant cost savings. Allowed for reinvestment in labor force and reallocation of resources.
Improve collaboration, eliminated inefficiencies, increased scalability and steam lined audits.