Statistics, Study Design & Methodology


Offering unrivaled expertise in biostatistics

By offering tailor made solutions with a strong focus on accuracy and quality, our clients can keep a track on timelines and costs are kept to a minimum. Our statisticians provide statistical support along the full development cycle of the drug, from early development to post-marketing lifecycle management, across a wide variety of therapeutic areas. Our biostatistics consulting group provides support for clinical development plans and/or individual study protocols, including study design, sample size calculation, and defining study objectives and endpoints.

Providing extensive support in complex statistical areas

Our statistical consulting group provides support for complex statistical methodology and innovative and adaptive trial designs, handling of missing data, regulatory guidance for strategic development and support at meetings with global regulators. Venn Life Sciences also offers extensive support for Data Safety Monitoring Board (DSMB) / Data Monitoring Committee (DMC) meetings, including development of charter and provision of unblinded statistician.

Venn Life Sciences offers support in:

Study Design & Methodology Services

  • CDP (Clinical Development Plan) and Study Design
    • Methodology CDP and study design
    • Complex/innovative (adaptive) designs
    • Sample-size calculations
    • Simulations
    • Advisory committees
  • Regulatory support
    • Special Protocol Advice / Scientific Advice / Pre-IND meetings
    • MAA submissions
    • Answers to regulatory authority questions
  • Training
    • Internal
    • External

Statistical Services

  • Statistical Part of the protocol writing
  • SAP (Statistical Analysis Plan) writing
  • Programming:
    • ADS (Analysis Datasets)
    • TFLs (Table, Figures and Listings)
    • CDISC standard
    • Source Version control System used to track all changes
    • Quality Control (Plan, Documentation)
  • TFL deliverables
  • Statistical reports

Data Safety Monitoring Board (DSMB) / Data Monitoring Committee (DMC)

  • Oversight of independent statistician:
    • Elaborate unblinded results for DSMBs/DMCs or interim analysis
    • Guarantee the unblinded posture/state of the statistical team
  • Charter writing
  • TFLs preparation
  • Meeting’s attendance

Learn more about Statistics, Study Design & Methodology

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