Expert Statisticians

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