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Biostatistics & Statistical

Programming

Precision Biostatistics
for Cutting-Edge Clinical Research

At Summit Clinical Research, we specialize in providing dedicated biostatistics and statistical programming services tailored specifically for our Sponsors and industry partners engaged in Steatotic Liver Disease (SLD), Obesity, and Alzheimer’s studies.

Our biostatistics and statistical programming team goes beyond traditional services by offering a comprehensive understanding of the complexities of Steatotic Liver Disease (SLD), Obesity, and Alzheimer’s studies. This means our statisticians and statistical programmers possess in-depth knowledge of the disease, supporting accurate and meaningful data interpretation.

Collaborating closely with our medical science team physicians, our experienced biostatisticians and statistical programmers provide the highest quality reporting for your Steatotic Liver Disease (SLD), Obesity, and Alzheimer’s studies, while also minimizing any unexpected data issues that may arise.

Rest assured that when you work with us, you are partnering with a team of highly qualified experts in biostatistics and statistical programming who are dedicated to delivering exceptional results for your Steatotic Liver Disease (SLD), Obesity, and Alzheimer’s research projects.

Study Initiation Services

  • Protocol Review & Writing
  • CRF/eCRF Design Input
  • Creation of Statistical Analysis
  • Plans (SAP) and Mock Shells for Tables, Listings, and Figures (TLFs)

Data Analysis & Reporting

  • SDTM: Creation of regulatory-compliant CDISC SDTM datasets from Electronic Data Capture (EDC) and various external data sources
  • ADaM: Creation of specifications for ADaM datasets, programming and validation of ADaM datasets following CDISC ADaMIG
  • Programming of Tables, Listings and Figures

Submission Services

  • Submission package preparation
  • Integrated Summaries of Safety & Efficacy (ISS/ ISE)
  • Bioresearch Monitoring (BIMO) listings

Additional Services

  • Vendor/CRO oversight
  • Statistical Consultancy
  • CDISC Consultancy
  • Screen Failure Analysis
  • Statistical Programming Training

What Sets Us Apart?

Partnership

Summit Biostatistics and Statistical Programming team is your success partner. We go above and beyond and strive to meet your objectives. We work together until we achieve client satisfaction.

Accuracy

With our robust quality control procedures, we help drive precision and quality of statistical programming activities at every stage of your clinical trial.

Study Expertise

Specializing in Steatotic Liver Disease (SLD), Obesity, and Alzheimer’s studies sets us apart, showcasing our in-depth knowledge and dedicated focus on delivering high-quality solutions in these complex therapeutic areas.

Collaboration

The Summit Biostatistics and Statistical Programming team collaborates closely with Medical Science teams throughout the data analysis process. All tables, listings, and figures undergo thorough review and discussion with medical monitors.

Our Team

Our Biostatistics and Statistical Programming team comprises highly skilled professionals with diverse experience in multiple therapeutic areas and clinical research phases. They possess in-depth expertise in CDISC standards and are well-versed in regulatory requirements established by authoritative bodies like the FDA, PMDA, and EMA.

Customized Solutions

Recognizing that each client has unique support requirements, we offer tailored solutions designed to meet your specific needs.

Interested in learning more about our biostatistics and statistical programming services?