Statistics, Pharmacokinetics and Scintigraphics
Our statistical, pharmacokinetic and scintigraphic experts understand early phase studies and their specialist challenges. We work with our sponsors to optimise study objectives, design, subject numbers and maximise use of study data.
- Our statistical staff provide input into clinical protocols and designs, including sample size estimations and randomization, interim analyses, final analysis and ensure all output complies with the relevant International Conference on Harmonization (ICH), the Committee for Medicinal Products for Human Use (CHMP) and Food and Drug Administration (FDA). Our statisticians also have experience in the use of adaptive trial methodology relevant to early phase studies.
- Our PK experts provide data analysis and interpretation, routinely undertaking interim assessments to assist in real-time, decision-making processes. Our staff will work with you to review and evaluate next step for your study. They also work closely with our data management, statistical and medical writing staff to provide an integrated and comprehensive pharmacokinetic offering for inclusion into the study CSR.
- Our scintigraphic analysts provide expert review and interpretation of scintigraphic data, providing both qualitative and quantitative analysis of drug product performance and pharmacodynamic effects during a study.