Global Pharma Partners With eClinical For Rave Testing
A top ten global pharmaceutical company dedicated to utilizing Medidata’s Rave platform deploys between 50 – 100 new studies in a given year. The organization needed to ensure they maintained a high level of quality through incorporating defined quality processes and testing, but without increasing internal resources to support this functional testing. Their objectives included:
- Identify a flexible service model that was truly scalable and could accommodate a varying level of clinical study builds ranging from 50 to 100 in a calendar year.
- Partner with an organization that had a long and rich history leveraging Medidata’s Rave platform and had the technical expertise to support and supplement their functional testing efforts.
- Partner with experts that embrace a “zero-defect” mindset and has reputation and experience that could provide industry leading quality deliverables.
- Establish a process that is seamless with their internal team to ensure that database go-live targets are met.
eClinical Solutions consulted with client and identified specific quality “check points” whereas experienced Rave programmers performed functional testing of edit checks, custom functions, and tested the overall study database.
- eClinical Solutions identified resources that were trained and/or certified on Medidata Rave and established a scalable internal process to accommodate the volatility of testing requests based on monthly study starts.
- eClinical implemented their rigorous Quality Control process to ensure that every item tested met functional requirements, and documented results accordingly. Utilizing their established methodologies developed by their EDC team, the testing supported 100% test coverage to release a “zero-defect” study database.
- Oversight established internally through Quality Assurance head to ensure that all deliverables met high standards and that all work was documented accordingly.
- Global Not For Profit Empowered by Standardization of Technology and Clinical Data
- The Importance of Training for Clinical Trial Data Professionals