Strategic biometrics consulting
Senior consulting expertise in study design, statistical methodology, regulatory strategy and submission planning across every stage of clinical development.
Senior biometrics and statistical consulting, right where you need it
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Biometrics Consulting
Aligning data strategy with study decisions.
- Vendor & data oversight
- Programme governance
- Risk-based quality control
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Statistical Consulting
Shaping analysis around clearer evidence paths.
- Estimand & design strategy
- SAP authoring
- Adaptive & Bayesian methods
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Medical Writing Consulting
Guiding documents from first draft to submission.
- Submission document strategy
- ICH-aligned guidance
- Author review & training
Consulting capabilities across the biometrics lifecycle
From study design and advanced statistical methods to regulatory strategy and submission support, we bring specialist expertise where your programme needs it most.
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Statistical planning & design
Modelling and simulation, sample-size estimation, and estimand and intercurrent-event strategy that set trials up to succeed.
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Advanced statistical methods
Adaptive and seamless designs, interim decision-making, adaptive dose-finding, Bayesian methods, complex modelling and principled missing-data handling.
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Regulatory strategy & representation
Navigating FDA and EMA requirements with expert advice, representation in agency interactions, and filing-ready submission support.
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Compliance & inspection readiness
Statistical training, audit preparedness and data-integration strategies that keep programmes inspection-ready.
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Data quality & independent oversight
Data-quality monitoring strategies and technologies, plus independent data monitoring for trials that require genuine separation.
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Statistical & scientific writing
Statistical, medical and scientific writing that turns complex analysis into clear, submission-grade documents.
Specialist expertise for your most complex development challenges
For more than 35 years, we’ve helped teams navigate complex biometrics challenges with scientific rigour, practical thinking and close collaboration.
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Strategic expertise from day one
Senior statistical thinking that shapes planning, sharpens decisions, and moves your programme forward.
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Regulatory confidence
Consultants with deep FDA and EMA experience for regulatory interactions, independent expert opinions, inspection readiness and submission support.
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Faster, more flexible decisions
Agile thinking that delivers practical solutions when conventional approaches — or timelines — are not enough.
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Trusted specialists for complex trials
36 years of biometrics expertise trusted by pharmaceutical, biotechnology and medical-device sponsors.