Clinical Trial Management System (CTMS) Upgrade

Overview

A top Fortune 500 pharmaceutical client wanted to upgrade their Clinical Trial Management System (CTMS) from a customized, homegrown instance to an off-the-shelf, commercially available product.

Target

Within a 30-month time horizon, facilitate a rigorous platform assessment effort, select a “winner” application based upon documented customer requirements and proceed with a global implementation and systems rollout.

Solution Delivery

This program was performed in 2 parts: 

• Part I: Initially, eta one was called upon to partner to provide a business case assessment, conduct an RFI (Request For Information) and evaluate the follow up RFP (Request For Proposal).  This analysis effort concluded with a formal recommendation based upon the information collected.

• Part II: Following the analysis effort, our client made a data-driven decision to utilize a specific solution (Oracle Siebel).  During the execution effort, eta one was engaged to perform program management, testing, training and rollout expertise.

Results

Our client was able to make an unbiased platform selection that was supported by data.  Following this, the off-the-shelf product was configured to their specific needs based upon documented requirements.  The instance was then validated according to these requirements and successfully rolled out worldwide.  Data entry errors, which were present in the original system, were virtually eliminated using system validation rules.  In addition, by leveraging database linkages and an improved UI, data entry time was reduced by approximately 25%.