CDISC Guidelines & PK/PD Streamlining Drug Development

Leveraging CDISC Standards : Enabling a More Efficient Regulatory Submission and Review Process

Leveraging CDISC Standards Enabling a More Efficient Regulatory Submission and Review Process

As an industry leader in PK/PD CDISC standards, Allucent’s expertise in generating datasets for legacy, planned, and ongoing studies ensure your program’s compliance with the FDA’s required CDISC standards.

Our services include interim PK/PD data review, noncompartmental Pharmacokinetics analysis (NCA), SDTM and ADaM dataset generation, Tables, Listings, and Figures (TLFs), data specification for Define.xml file facilitation, and Abbreviated Reviewer’s Guides (RGs). Our clinical pharmacology experts work seamlessly to analyze and organize your data to help guarantee your program’s datasets are CDISC compliant. 

For a more comprehensive overview of our CDISC expertise, download the fact sheet.

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