Navigating the Path for Pharmacokinetic CDISC Data Preparation

Maria Saluta

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 […]

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Topics: PK/PD Modeling & Simulation

Streamline CDISC Electronic Data Submissions: Technology Solution for CDISC PK Study Data

Through our collaborations with regulatory agencies, and partnerships with major global nonprofits, we, at Certara, continuously strive to provide up-to-date solutions to help streamline the drug development process for our clients. Beginning at the end of 2016, in a continuing effort towards international harmonization across regulatory agencies, the US Food and Drug Administration (FDA), the […]

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How to Manage Pre-clinical Data as a Strategic Asset

Stuart Horowitz

A recent report by Deloitte identified the #1 trend in the life sciences market as an increased focus on patient safety and enforcement. While it seems obvious to consider safety issues in approved drugs, regulatory agencies such as the FDA and EMA (European Medicines Agency) are extending their scrutiny to the entire drug development process, […]

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Topics: Scientific Informatics