Patient Perspectives on Irritable Bowel Syndrome

Expert Statisticians

We provide a range of services to our clients including statistical advice, analysis and training.

Statistical support for a streamlined clinical development plan

Including the best sequence of clinical trials from phase I to III, optimal study design; randomization planning; establishment of priorities; sample size estimation; selection of end points and analysis methodology. Approval of development plan by regulatory agencies: EMA and FDA.

Optimal design of each study protocol

Literature review, proposal of various design options, expert statistical insight into study design, use of modern statistical techniques (adaptive, Bayesian, group sequential, seamless), sample size calculation for a successful study, selection of endpoints and most relevant statistical methodology, statistical contribution to and review of final protocol, ERB/regulatory approval support for trial.

Regulatory strategy for Biostats

Identification of documentation needed; guidance for FDA interaction, Phase II and pre-NDA meetings; preparation and presentation of documents; briefing book; questions to anticipate.

Innovative statistical methodologies for the design and analysis of clinical data

Adaptive dose finding, adaptive sample size re-estimation, Bayesian modelling, seamless phase II/III, group sequential approach, network meta-analysis, population PK/PD modelling, patient enrichment approach, causal inference, data mining.

Safety monitoring

Reviewing safety data throughout the course of the study; DSMB/DMC charter, statistical support to pharmacovigilance, annual safety reports, establishment and coordination of safety database.

Consulting on ISS/ISE

Identification of data to pull together from different studies; analysis plans for integrated reports, production of ISS/ISE and regulatory support.

Collaboration with your clinical and regulatory groups

Cross-functional strategy and design of studies so they are acceptable to both EMA and FDA, contribution to regulatory documents, meetings and IND packages, statistical support for a successful drug approval.

Quality and project management

Work performed by qualified and trained personnel, following good clinical practices, according to own and customer SOP, project management for timely planning and delivery of quality work products.