Our statisticians have vast experience with medical device companies, pharmaceutical companies, medical, and biological research. We have a common language with researchers, clinicians, and physicians, and can translate your medical problem into a statistical question.

Our comfort with a wide range of higher-level statistical methodologies and our expertise in applying them makes us capable of assisting with virtually any problem. We are committed to providing excellent services to support your product from the design stage throughout the lifespan of your project including:

 

• V&V tests

• Bench tests

• Preclinical (Animal) Studies

• Early Phase Drug Studies

• Pilot, Proof of concept, Feasibility Studies

• Process Control (for manufacturing)

• Journal publications and posters for conferences

 

Our team of high-level biostatisticians, constantly updated with cutting-edge statistical methodology to meet regulatory requirements, can assist you with:

• Devising appropriate study designs (one arm, two-arm studies, adaptive design, seamless phase I/II, cross-over, etc.)

• Formulating and defining endpoints and acceptance criteria

• Formulating and phrasing statistical hypotheses

• Sample Size Assessment

• Randomization

• Statistical Analysis Plan – Outlining appropriate data-analytic strategies and tests

• Interim analysis plan

• Statistical analyses

• Statistical summary and Interpretation of study results

• Representation at regulatory agency meetings

• Preparing for committee meetings

• Preparing and revision of manuscripts

• Ongoing and general statistical consulting – problem-solving

 

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