Biostatistics Services

MedTrials is focused on providing statistical support through efficient study design, statistical methods development and a thorough understanding of the analytical complexities which is critical to effectively interpret the study outcomes. MedTrials provides comprehensive data analysis and reporting suitable for your regulatory submissions, presentations, and publications.

MedTrials biostatisticians are industry experienced and have a strong knowledge of the industry in a wide variety of therapeutic disciplines. Our diversity of experience, based on sound statistical theory and current scientific knowledge, leads to a clear and accurate picture of your product’s unique characteristics. Careful biometric planning and execution promotes impartial yet compelling evidence-based solutions from valid, reliable, and well-represented data.

Services include:

Protocol design and development
Sample size estimation and power calculations
Randomization
Statistical analysis plan (SAP) development
Integrated summaries of safety and efficacy data
Generation and QC of randomization schedule
CDISC compliance and deliverables (SDTM, ADaM, Define files)
Interim and final data analysis
Statistical consulting
Statistical report writing
Topline analysis
Statistical SAS programming of tables, listings, and figures/graphs
Statistical support for preparation of abstracts, manuscripts, and presentations
Meta-analysis, data mining, and exploratory analysis
Data Monitoring Committee (DMC)/Data Safety and Monitoring Board (DSMB) participation

Data Management

Through comprehensive data management solutions, MedTrials partners with you to ensure that the information generated from your data is valid, reliable, complete, and accurately reported.

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