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.
Consulting on ISS/ISE
Collaboration with your clinical and regulatory groups
Quality and project management
We will be pleased to hear about your trial project and provide you with a tailored-made, cost effective biometrics solution.
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