Biossec, CRO specialized in Biostatistics

Providing a large scope of biostatistical Services, Expertise and Consulting applied to clinical trials. Biossec covers strategic and operational activities with the engagement of quality, innovation, advice, transparency and respect for deadlines. Our activities comply with GCP guidelines and applicable national and international regulatory guidance.

Services

 Statistical methodology

 Randomisation - IWRS

 CDISC and Statistical Programming

 Statistical analysis

 Quality control

Expertise

 Clinical development planning

 Resolution of statistical issues

 Interim analysis

 Sample size re-assessment

 Interaction with health authorities

Consulting

 Project management

 Management of a Biostatistical Department

 Management of CRO

 Creation/Review of SOPs

 Management of statistical risks