Obtain independent statistical regulatory reviews of meeting documents and study-related documents. Define study endpoints (including patient-reported outcomes) and analyses that are acceptable to regulators. Obtain an independent statistical regulatory evaluation and interpretation of clinical study results. Then we are here to guide you. Upfront preparation leads to the best possible regulatory submissions, fewer review cycles and, ultimately, getting safe and effective drugs to patients as early as possible.
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Our regulatory and industry experiences make us unique in solving your regulatory, endpoint, statistical and trial design challenges. Because we understand the challenges facing both industry and regulators, we help you anticipate regulatory hurdles and guide you to successful regulatory submissions.
If you are like most clinical teams and sponsors, you wonder what questions FDA and other regulators will ask when they review your submissions (e.g., protocols, SAPs, briefing documents, CSRs). We are the bridge between psychometricians who develop instruments and clinical trialists who design and analyze studies. We are statistical experts in the design and analysis of clinical studies, and the interpretation of study results.
We are statistical experts in the design and analysis of clinical studies, and the interpretation of study results. Because we recognize studies must meet the needs of internal and external stakeholders, we help you balance your needs with those of regulatory authorities. From our years of experience at FDA and in industry, we understand the expectations of both regulators and industry.
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