Statistical Programming

When you require accurate and efficient statistical programming CRO services, MMS is your first choice.

When faced with an urgent delivery, MMS knocked it out of the park. This Biometrics team is one of the best I’ve worked with.
Head of Biometrics
Large Pharma Sponsor

Sponsors come to MMS statistical programming experts for three things: accuracy, innovation, and knowledge. A deep bench ensures that knowledge flows throughout the project team and cross-functionally for strong datasets, analyses, and other outputs. Resulting from this is fewer drafts, a smoother review process, and time saved for every Sponsor.

Programming Innovation & Quality
Along with expertise in SAS & R our experienced team has the advantage of proprietary tools and AI, to aid in the efficiency and automation of programming deliverables.
 
Complete Support
Comprehensive support across the entire drug development lifecycle, including Phase I-IV clinical trials, 120-day safety updates, AD-Hoc requests, HTA, RWE, BIMO, integrated summary of Safety/Efficacy (ISS/ISE, data anonymization), and SEND datasets.
 
Data Integration & Standardization
Creation of CDISC compliant SDTM/ADaM datasets and specifications, including legacy data conversion to industry standards and up-compliance for legacy data if needed. Creation of analysis tables, listings, and figures (TLFs), planned, ad-hoc, and/or rescue to the highest standards.
 
Submission Readiness         
Submission readiness for the creation of submission-ready datasets and specifications, annotated CRFs, define files, and reviewers’ guides.

Services Provided
  • 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
Immutable Tables

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.
Exceptional Quality & Efficiency

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.Exceptional Quality & Efficiency

Rescue Studies

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.

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