Biostatistics Systems

Clinquest’s biostatistics software has been validated according to ISPE/GAMP 4 industry best practices, which are acknowledged by both EU (PIC/S) and U.S. (FDA) Regulators.

For Phase I, II and III clinical studies, primary endpoint analysis are independently programmed by a second statistician. Additional validation steps are identified when necessary, in collaboration with the client.

Click here for more information on Clinquest’s Data Management services.