Services

Through our cloud based Kapture EDC system we are able to collect data on any browser on any device whether that be with a desktop/laptop computer or IPAD/tablet (www.datakapture.co.uk)

Our Data Management services include: CRF design, check writing and EDC data review (with query generation, resolution, reporting and regulatory compliant audit trail), data exports for derivation and structuring prior to analysis, medical data coding with (WHO/MedDRA dictionaries) as well as quality control.

We provide a standard ‘In house’ service using our own Kapture Clinical Data Management System (CDMS). This application is built on the latest industry standard Microsoft platforms and powered by Amazon Web Services to ensure it is fast and reliable. The CDMS is fully validated, documented and 21 CFR part 11 compliant.

Alternatively our data managers can work with off the shelf EDC/CDMS if required.

Our statistical consulting services include: Protocol Design, Sample Size Investigations, Statistical Analysis Plans and supporting Table, Figures and Listing Shells, Statistical Report and Clinical Study Report writing.

Working closely with the statisticians our team of SAS programmers apply analytical methods and produce tables and appendices for 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:

Adaptive Designs
Interim analysis, Sequential analyses, Incorporation of trial changes to preserve of Type 1 error rate, Fishers combination test and Incorporation of closed testing procedures.

Survival Analysis
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.

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.