Certara is the leading drug development consultancy with solutions spanning the discovery, preclinical and clinical stages of drug development.
Data heterogeneity is a regulatory reviewer’s nightmare. Some sponsors talk about patient “gender” whereas others list the patient’s “sex.” What about date formats? Do you use the American-style month-day-year format or the European-style day-month-year? Inconsistent data presentation makes both collaborating on drug development projects and reviewing regulatory submissions more difficult. To address this challenge, the […]
Read MorePRINCETON, NJ – Apr. 19, 2017 – Certara today announced the launch of a new solution for preparing, analyzing and submitting PK data in Clinical Data Exchange Standards Consortium (CDISC) format. CDISC supports the acquisition, exchange, submission and archiving of non-clinical and clinical data.
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