Methodology, Study Design & Biostatistics Consulting

Adequate study design and statistical methodology are key elements for the success of a single clinical trial or a whole clinical development plan. Our experts in study design, methodology and biostatistics for clinical trials can help sponsors in successfully designing and analyzing their clinical trials and in their interactions with Regulatory Authorities about study design and/or results.

Click to read: Recent Scientific Publications

Why partner with Venn’s Methodology, Study Design and Biostatistics Consulting Team?

We can support customers with the following services:

• Clinical Development Plan / TrialDesign Consulting

Our team can advise on a wide range of trial designs, including complex ones, helping the sponsor to translate hypotheses into feasible study protocols, that are compliant with regulatory expectations and guidance, including the new “estimands” framework as recently introduced in the R1 revision of the ICH-E9 guideline.

Our experience covers the following topics:

• • formulation of objectives, identification of endpoints, formulation of statistical hypotheses, definition of estimands
  • sample-size calculations
  • simulations to document the statistical properties of complex designs and/or to choose between several alternative designs
  • development of group sequential designs
  • futility interim analyses
  • adaptive designs
  • sample size re-estimation
  • multiple endpoints
  • design and implementation of equivalence/non-inferiority trials
  • small populations and orphan diseases
  • metaanalysis
  • advisory board participation

• Discussions with Regulatory Authorities on development plans and trial design (Special Protocol Assistance, Pre-IND, End of Phase 2, Scientific Advice… meetings)
• Consulting in advanced Biostatistics (Bayesian statistics, Multistate modeling, Latent Variable Modeling, Generalized Linear Mixed Modeling…)
• Computer simulation of clinical trials
• Statistical Analysis Plans development
• Review and interpretation of statistical trial results
• Sensitivity/robustness analyses
• Exploratory analyses (e.g. subgroup analyses, characterization of responders…) to generate hypotheses for further research and next steps of development
• Scientific Publications
• Acting as independent statisticians on study committees (iDMCs, DSMBs, Event Adjudication Committees…)