• Services : Methodology, Statistical Methods, Sample Size, Randomisation IWRS, Statistical Analysis Plan, SAS Programming, Statistical Analyses, and Quality Control.
• Expertise : Clinical Development Plan, Complex Statistical Methods, Resolution of Issues, Interaction with Health Authorities, Participation to iDMC or DSMB, Interim Analyses, and Sample Size Re-assessment.
• Consulting : Project Management in Biostatistics, CRO Management, Statistical Risks Management, Creation and Review of SOPs, Process Improvement, Management of a Biostatistical Department.
• Ensure a high level of quality,
• Efficient communication,
• Team spirit, rigor, positive and creative attitude,
• Transparency on the progress status,
• Added Value through free advice applied all along the project.
All our deliverables are performed by qualified, experienced and trained persons,in compliance with regulatory guidelines, and using a quality system including SOPs validated by a QA officer.