November 8, 2023

Clinical Data Management

Use Case 1:

Our client is an emerging Pharma company with treatment solutions in multiple therapeutic areas. They wanted to create a stable data management study development team in-house. We provided an FSP solution to create an extension of their Data Management team and ran a seamless operation with Data Managers, eCRF Developers and Medical Coders, despite time zone differences, with the global team. The client was able to use the experienced resources from Ephicacy for a market-leading EDC product, reducing the trainings and KT time lag. Once the study development cadence is established, clients focus on developing data standards for streamlining their processes.

Use Case 2:

Our client couldn’t find qualified resources and had a difficult time in retaining resources because of the market trends. Ephicacy with its large pool of current, past employees and their network along with a dedicated HR team, was able to find suitable resources. The study team got all the help they needed with the experienced Ephicacy team without any/least KT.

Use Case 3:

Our client approached us when their existing CRO couldn’t support the EDC platform and study conduct. We help validate their EDC URL changes to in-house setup with their IQ and OQ. We are creating the QA SOPs and best practice guidelines for the end-to-end data management processes. We help with their system administration, user administration and study archive processes.