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The regulatory affairs representative on the project team:
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Regulatory Affairs
Regulatory affairs is a critical part of iGATE Clinical Research project management, ensuring compliance with all relevant regulatory requirements in all stages of every project.The regulatory affairs representative on the project team:
- Prepares, tracks, and maintains clinical trial applications to the regulatory authorities
- Reviews and tracks regulatory and clinical trial documentation to ensure compliance with all applicable GCP and regulatory guidelines
- Works closely with the medical monitor to ensure that safety information is appropriately collected, evaluated, and reported, including serious adverse events and other significant safety events
