DATA MANAGEMENT AND STATISTICS

Data management clinical trialsTCRS works in collaboration with our strategic partners dataMagik. Like TCRS, dataMagik is committed to meeting our sponsors’ objectives by developing focused, efficient and cost-effective solutions-which we then implement to the highest standards of quality.

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.

Electronic Data Capture and Data Management

In keeping with TCRS and dataMagik’s philosophy, the EDC system is both adaptable and highly user-friendly.

It offers the ability to collect data via desktop/laptop computers, tablets (including IPAD), digital pens or “traditional” pen and paper. We have also developed highly innovative data capture approaches employing sensors that work with smartphones to record a range of body functions directly.

Our Data management system is built on the latest industry standard Microsoft platforms (.NET, HTML5, Silverlight and SQL). It is integrated with SAS software and is fully validated and documented.