Our extensive experience means that we can advise not only on individual protocol development but also whole drug programmes.
This extends from “First in man” and ‘Proof of concept’ trials through to Dose selection designs and other specialist adaptive designs all aimed to extend the speed the development process and increase knowledge of the compound.
We have considerable experience in assimilating and presenting Preclinical pharmacology, Toxicology, Clinical findings as well as Pharmacodynamic and Bio-disposition/Pharmacokinetic information at Regulatory development review meetings.
Our aim is to help clients to make the best possible informed decisions.
Through our cloud based dataKapture EDC system we are able to collect data in any format whether that be with a desktop/laptop computer, digital pen, IPAD/tablet PC or traditional pen and paper (www.datakapture.co.uk)
Our Data Management services include: CRF design, EDC data review, Manual ‘double key’ data entry (with query generation, resolution, reporting and full audit trail), Data importing to SAS for derivation and structuring prior to analysis, Data coding with (WHO/MedDRA dictionaries) as well as Quality control.
We provide a standard ‘In house’ service using our own dataKature Clinical Data Management System (CDMS). This application is built on the latest industry standard Microsoft platforms (.Net, Html5, Silverlight and SQL) and is integrated with SAS software. The CDMS is fully validated and documented.
Alternatively clients can manage their own data using our system or their own.
Our statistical services include: Protocol design, Sample size investigations, Statistical analysis plans and table shells, Application of analytical methods and Production of statistical reports.
We routinely integrate databases from multiple projects, undertake meta analyses and produce Integrated Safety Summaries. We also undertake Interim Analyses providing information on a regular basis to DSMBs.
We also provide expert reports and ‘state of the art’ publication and presentation services.
Our particular strengths are:
Interim analysis, Sequential analyses, Incorporation of trial changes to preserve of Type 1 error rate, Fishers combination test and Incorporation of closed testing procedures.
Log rank/Wilcoxon hypothesis tests, Cox’s proportional hazard modelling and Kaplan-Meier survival plots.
- Non-Linear Mixed modelling analyses of sparse data
- Repeated Measures Mixed model analyses of time series data
- Meta-analyses (Fixed and Random effects) for the combination of treatment estimates from individual trials and production of forest plots.