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. MMS clinical data managers know how to make EDC technology and surrounding processes work to ensure the integrity of every data set. Minimizing the risks associated with EDC and clinical data management, MMS experts help you capture clean and accurate clinical research data while meeting key and aggressive project deadlines. For sponsors, this equates to less time training for each project and more time running efficient trials. 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 and maximize the value of eClinical technologies
  • a wide range of therapeutic area experience, adding substantial value
  • proven processes to begin clinical studies faster, with accurate, clean results sooner
  • near real-time access to clean clinical data
  • a single point of contact, allowing sponsors to spend less time managing vendors and more time focusing on trial analysis and insights

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 can provide SDTM and ADaM datasets and TLFs based on CDISC compliant specifications, data anonymization, validation and gap analyses, Data Safety Monitoring Board (DSMB) support, and much more. Whether using SAS (Citrix), UNIX, client systems, or Julia, open communication within and across functions is what drives higher levels of success for this team.

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.

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.

View the webinar for free

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