Statistical Programming

• Creation of CDISC-compliant SDTM and ADaM datasets
• Generate planned and ad-hoc analysis TLFs
• Data anonymization
• SEND dataset and submission package support as per FDA requirement
• Development of submission ready define files, reviewers guide
• Support and recommendation for Bioresearch Monitoring (BIMO) package
• Validation and gap analyses
• Data Safety Monitoring Board (DSMB) support, Development Safety Update Report (DSUR) support, advisory committees, and IND reporting
• Open communication within and across functions driving higher levels of success

MMS programmers using proprietary technology are proficient at creating immutable tables which have several in-text applications for the MMS writing team and sponsors including but not limited to:

• increased efficiency and quality
• streamlined QC processes, and
• early messaging discussions, among others.

At MMS, every programmed deliverable (e.g. dataset, TFL, documentation) follows a three-phase process of quality control, validation and assurance, ensuring that we deliver to the highest standards.

MMS Statistical programming is specialized in the review and assessment of all study elements and identifying key issues that could be preventing study success.

Study rescue plans focus on resolving current bottlenecks and study challenges by introducing new strategies, such as expediting study schedules or finding other solutions to regain time and momentum.

Rescue studies are often challenging for any CRO, but MMS has been trusted with a considerable number of rescue studies by its sponsors with consistent success.