Set up
At CHDR, we incorporate pharmacokinetics and pharmacometrics from the earliest stages of trial planning to optimise study design and enhance resource efficiency. Our expert statistics team provides comprehensive support, including Statistical Analysis Plans (SAP), subject randomisation, and deblinding envelope preparation, alongside detailed power calculations to ensure reliable and statistically significant results. Our dedicated pharmacometrics team offers predictive PK/PD modelling and simulation to support study design and dose selection for (first-in-human) clinical trials, using preclinical or published data of existing compounds where applicable. Additionally, we optimise PK and PD sampling timepoints to minimise patient burden.
Conduct
At CHDR, we conduct interim analyses during studies to assess the safety and progression of treatment cohorts before database lock. These analyses help determine whether it is safe to increase the dose for the next cohort and provide accurate power estimations for the study. Interim analyses are always described in the protocol and, when applicable, in the statistical analysis plan (SAP).
Interim analyses are based on blinded data, with the exception of pharmacokinetic (PK) interim analyses, which use data from subjects receiving active treatment. Safety and pharmacodynamic summaries are presented by cohort or group, ensuring data remains blinded until database lock. In exceptional cases, summary graphs by treatment may be agreed upon by the principal investigator, statistician, and client. For PK data, concentration data and parameters are usually summarised and visualised, with individual graphs shown only in exceptional cases, ensuring blinding is maintained.
The results of interim analyses are reported separately, with blinded data being presented in one report and unblinded results, if applicable, in a separate one.
Reporting & analysis
At CHDR, we offer expert statistical analysis to ensure the accuracy and integrity of your clinical study data. If a Statistical Analysis Plan (SAP) is provided, analysis proceeds according to the plan; otherwise, it follows the study protocol, with any deviations documented in the statistical and clinical study reports. Data is exported from Promasys into a raw ASCII file (.txt or .CSV), accompanied by a SAS script that converts the data into a SAS-compatible format. The data is then cleaned and refined, addressing any inconsistencies found during the blind data review. We apply a standard statistical approach using SAS scripts, tailored as needed for each study. The final results are presented in a comprehensive statistical report, including listings, plots, tables, and figures, all aligned with the protocol or SAP specifications.
