The management of statistical deliverables is a critical part of the clinical trial conduct and also a growing requirement of regulatory authorities. Procedures, processes, plans, project management tools, trained, qualified and experienced people, quality assurance system, efficient communication, risk assessment, ... are defined as a standard to manage clinicals studies.
Biossec offers the following consulting services in Biostatistics :
• Project management,
• CRO management (local or international, global or specific, European or Indian, ...),
• Management of a Biostatistical Department,
• Process improvement,
• Creation and review of SOPs,
• Statistical risk management.
Biossec works closely and efficiently with its clients. With partners, Biossec may provide consulting and advice for data management, pharmacokinetics, medical writing and quality assurance. Our intervention can take place at the client’s site.