Data Management and Biostatistics

A high performing team of global data management, biostatistics, and programming experts.

Committed to the highest standards of quality, a shared sense of urgency, and a focused dedication to our sponsors’ success.

Data Management and Biostatistics Services

Driven by quality, the experts at MMS approach every data management and biostatistics deliverable as a top priority, no matter how big or small the project may be. And, you can expect in-depth, thoughtful conversations with team members, knowing that they are thought leaders, invited speakers, and change makers in industry groups across the globe. 

 

Clinical Data Management

Data management services at MMS are designed to make the process of design, collection, reconciliation, and review of clinical research data more efficient and reliable.  

Although our clinical data specialists manage all of the data, you stay in complete control — with continuous access to data and total transparency to study progress.  

Working with MMS provides:

  • An experienced team to help manage studies across a variety of industry standard EDC platforms;  
  • Expertise to recommend and deploy cutting-edge “e” or electronic technologies including ePRO, eCOA and eConsent with minimal expense and no disruptions; 
  • A wide range of therapeutic area experience;
  • proven processes to begin clinical studies faster, with accurate, clean results more quickly; 
  • near real-time access to clean clinical data; and 
  • A single point of contact, allowing sponsors to spend less time managing vendors and more time on trial analysis and insights

MMS Clinical Data Managers provide: 

  • Knowledge on EDC technology and surrounding processes and how to ensure the integrity of every data set 
  • Minimization of risks associated with EDC and clinical data management by capturing clean and accurate clinical research data 
  • The ability to meet key and aggressive project deadlines 
  • A reduction in Sponsor’s training time for each project so they can spend more time running efficient trials 
    Statistical Programming

    With extensive submission experience, MMS statistical programmers across North America, Asia, Europe and South Africa deliver strong statistical programming support to sponsors through state-of-the-art processes, systems, and skill.  

    Accountability and consistency in resources has cultivated a culture of shared ownership, extending to sponsors – especially when long-term clinical trials are involved. This ensures on-time delivery with fewer drafts, easing the process for your review team. 

    MMS statistical programmers provide, among others: 

    • SDTM and ADaM data sets and TLFs based on CDISC compliant specifications  
    • Data anonymization 
    • Validation and gap analyses 
    • Data Safety Monitoring Board (DSMB) support whether using SAS (Citrix), UNIX, client systems, or Julia 
    • Open communication within and across functions driving higher levels of success  

      Immutable tables: 

      MMS capabilities includes technology to utilize immutable tables in its documents. The use of immutable tables has shown advantages for Sponsors that include increased efficiency and quality, streamlined QC processes, and early messaging discussions, among others. 

      Biostatistics

      The role of a biostatistician is key to the successful planning and execution of a development program, and the expert biostatisticians at MMS hold the trust of leading pharma and biotech sponsors.  

      The MMS biostatistics team has an incomparable, industry-educated skillset to provide the proper consultation for: 

      • traversing sample size calculations, randomization schedules, statistical analysis plans (SAP), data interpretation, and more 

      When sponsors engage an MMS biostatistician, they are guaranteed clarity in communication with all team members, including programmers, data management, data scientists, medical writers, and clinicians.  

      The success of a clinical trial can depend on the strength and knowledge of a biostatistician. When supporting sponsors with statistical analyses and protocol development spanning health authority responses and publication support, the biostatisticians at MMS are attentive, methodical, and intuitive. 

      Data Science

      The Data Science experts at MMS open new possibilities for sponsors searching for data-driven insights for pharmaceutical, biotech, and healthcare organizations. The team employs a wealth of regulatory expertise, strong processes, and purpose-built, flexible technology to drive efficiency using real world data (RWD). This leads to uncovering new insights on disease, compound, patient, and possible operational improvements for those involved in life-sciences and research. 

      Learn more about Data Science services at MMS.

      Related Client Case Studies

      Successful NDA Submission Programming


      Presented by MMS statistical programming leaders, this webinar details the Biometrics Operational Data Model and explains how submission work can be streamlined across programmers and statisticians. Additionally, the team delves into validation, reviewer’s guides, trial domains, and items often overlooked during submission planning.

       

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