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.

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

We can support customers with the following services:

• 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 draft R1 revision of the ICH-E9 guideline.

Our experience covers the following topics:

• • design and implementation of equivalence/non-inferiority trials
  • development of group sequential designs
  • futility interim analyses
  • adaptive designs
  • sample-size calculations and simulations to document the statistical properties of complex designs
  • small populations and orphan diseases
  • metaanalysis

• 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…)