lsafety

MedDRA Integration

Ensure the data in your CARA Life Sciences Platform meets the standards and norms of the MedDRA dictionary / thesaurus.

What is MedDRA?

A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Why is it used?

MedDRA provides a rich and highly specific standardised medical terminology to facilitate sharing of regulatory information internationally for medical product used by humans.

How will we use it?

By integrating the CARA Platform with governed and regulated dictionaries from MedDRA, CARA Life Sciences products will provide internationally standardised terms in the regulated industry. These terms would be used in registration, documentation and safety monitoring of medical products both before and after a product has been authorised for sale. This includes all applications in pharmaceuticals, biologics, vaccines, and drug-device combination products.

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