THE CHALLENGE: Project Delays Threaten On-Time Delivery of SAP and Final Study Results
A large pharmaceutical company and their development partner were finalizing the Statistical Analysis Plan (SAP) and preparing for final reporting in order to present at an upcoming shareholder’s meeting. With the presentation date quickly approaching, however, their progress was slow due to delays in finalizing the database and questions related to the quality of the SAP. Concerned they would be unable to compile the necessary data and complete the appropriate analysis on time, they reached out to MMS for help.
MMS SOLUTION: Rapid Response Team Deployed for Additional Expert Assistance
With the client quickly running out of time to meet their deadline, MMS assigned a rapid response team to immediately begin work to revise and finalize the SAP. Part of MMS’s Adaptive Parallel Processing system, the team consisted of highly skilled and experienced experts in the various areas related to the project deliverables. After analyzing rate limiting steps and correcting inaccurate and inconsistent data in the previous analyses, the MMS rapid response team provided a completely revised SAP within two weeks, programming and validation within four weeks, and a top line report of trial results within three days of database lock.
THE OUTCOME: SAP Completed / Trial Results Available / Client Prepared
According to the Sponsor, MMS delivered all the necessary data and reports in a fraction of the time it would have taken their internal resources and their prior collaborating CRO to do the same task. As a result, the pharmaceutical company and their development partner had their SAP in hand and their trial results ready to go well in advance of the shareholder’s meeting.