Biostatistics Services

Clinical Biostatistics Services

Care by the numbers.

With data on your side, you’re better equipped to make thoughtful decisions at every phase in clinical development and commercialization. Our Clinical Biostatistics team digs into your numbers to help you plan, execute, and analyze at every turn.

With nearly 200 dedicated biostatisticians on our team, we can lend a hand with:

  • Improved drug/device development performance
  • Smarter trial design
  • Reduced risk
  • Focused data insights
  • Fraud detection

Our team has deep understanding of the following areas:

  • Group-sequential and adaptive trial design
  • Data Monitoring Committee (DMC) support
  • Observational research/non-interventional studies
  • Biosimilars

 

Core Biostatistics Services: 

 

Biostatistics Services Offered Through Your Development Journey
Planning Execution Reporting & Interpretation Submission
  • Study design
  • Study optimization
  • Clinical development plan optimization
  • Study simulation
  • Strategy development for data integration and regulatory submission
  • Protocol/SAP development
  • Preparation of briefing documents
  • Preparation of and attendance presentation at Health Authority meetings including feedback review
  • Datasets and TFL production
  • Data surveillance
  • Application of powerful and innovative statistical methodologies
  • Fraud detection
  • Risk benefit assessments
  • Expert review of key results and statistical assessment
  • Reporting of key results
  • Preparation of briefing documents
  • Preparation of and attendance presentation at Health Authority meetings including feedback review
  • Response to regulatory or other agency questions (ethics committees, reimbursement agencies)
  • FDA Advisory Committee Meeting support, oral explanations with regulatory bodies, etc.
  • Data integration across studies for safety and efficacy
  • Input to CTD summary documents
  • Generation of electronic datasets and documentation
  • Rapid response support

The Right Experience for the Right Job

Our Biostatistics Team consists of highly educated and skilled statisticians.

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