We provide a range of services to our clients including statistical advice, analysis and training.
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.
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.
Identification of documentation needed; guidance for FDA interaction, Phase II and pre-NDA meetings; preparation and presentation of documents; briefing book; questions to anticipate.
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.
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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