A More Efficient Core Build with Rave RTSM and Rave EDC

"Medidata operational support has made us more efficient by enabling us to reallocate resources to focus on what's most important - clinical research."
-Zlata Pavlova Lead Data Manager, PSI

$20K

in savings per amendment in protocol changes

900

fewer hours spent reconciling

The Challenge: 

PSI resources were spread thin managing a complex study coordinating between internal teams, across different study management departments, help-desk support, supply management depots and balancing client needs over three continents and multiple time zones.

The Solution: Medidata operational support 

To meet these study demands, PSI adopted Medidata's operational support model with a dedicated Medidata resource to support PSI during study conduct. The relationship enabled Medidata Professional Services, including the Project Manager (PM) and Implementation Consultant (IC) to perform 100% of the core build process using Rave RTSM & Rave EDC for PSI studies. With the operational support model, all post go-live setup in Rave RTSM were completed by Medidata PM and IC. This included randomization and trial supply setups (e.g kit lists, supply plans, release, etc). The teams maintained ongoing communication including weekly check-in calls between Medidata, PSI & the sponsor.

The Benefits: 

The operational support of Medidata's Professional Services freed up time and resources for the PSI team and they were able to reallocate resources and focus on other tasks. The model eliminated the hassle of learning a new system and PSI benefited from consulting and best practices from the experienced PM and IC.  All post go-live setup and ongoing supply updates in Rave RTSM were managed by Medidata as well as monitoring supplies and shipments alongside the client supply manager. PSI realized cost savings by working with Medidata to generate patient randomizations lists in Rave RTSM as opposed to outsourcing this expense to a statistican to generate the list.