Statogen Consulting, North Carolina, is multi-disciplinary team experienced in Biostatistics, Statistical Programming, Data Management, Product Development, Regulatory Affairs, Due Diligence and Partnering, specializing in the biotechnology, pharmaceutical and medical device industries.
The team has a profound understanding of the development environment in the United States and Europe.
We support our clients at every step of the product life cycle - from early stage development to post-approval activities.
We have had plenty of experience applying principles of adaptive trial design, recurrent events analysis, meta-analysis, modeling and simulation, and serving on data and safety monitoring boards.
Our services include the strategic establishment and assessment of development plans and regulatory documents, product candidate and portfolio due diligence, trouble-shooting, agency meeting preparation and partnering support.