statistics

We offer efficient, high-quality, data management and statistical support for early phase clinical trials, whether done at HMR or elsewhere. We follow CDISC (Clinical Data Interchange Standards Consortium) standards, including CDASH and SDTM, to boost efficiency and to ensure that our data comply with all regulatory requirements. We supply a flexible, bespoke service, using either our own or our customer’s templates and standards.

Protocol – our statistical input includes trial design, sample size calculation, statistical methods, and consultancy advice during trial setup

Randomisation – we advise on randomisation strategy in complex trials, and generate randomisation lists and emergency unblinding envelopes

Statistical Analysis Plan – our experienced statisticians prepare SAPs,  including output shells

Interim analyses – we analyse PK and PD data with a very rapid turnaround, to support dose-escalation decisions. We ensure that blinding is fully protected by carefully structuring data output, using a statistician and unblinded SAS programmer who are independent of the trial team

Pharmacokinetics – we derive PK parameters, in plasma, serum and urine, for interim and final analyses. Our statisticians have extensive experience in bioequivalence, drug-drug interaction, repeated-dose, bridging, and dose-proportionality trials

Output production – we program all tables, figures and listings, using SAS. Our comprehensive QC procedures, including independent programming, ensure that we deliver high-quality output every time

Statistical consultancy – we offer statistical consultancy on other aspects of clinical development, including shelf-life estimates, and validation of laboratory assays