DATA MANAGEMENT AND STATISTICS

Data management clinical trials

For provision of biometrics services TCRS works in close collaboration with our strategic partner Syne Qua Non.

Statistics

Working in close partnership with our sponsors we develop innovative statistical designs and analytical methods across a wide range of therapeutic areas.

Experience includes – Bioequivalence assessment, Dose proportionality, Standard non-compartmental modelling for pharmacokinetics, Non-linear mixed modelling for population pharmacokinetics, Dose ranging, Sequential and adaptive designs, Biosimilar evaluations with replicated crossover designs and staged analyses as well as Meta Analyses with fixed and random effects.

More routine analytical techniques include sequential and adaptive designs, survival analysis and repeated measures both in phase II (hypothesis testing) and phase II (confirmatory) settings.