AnaCipher Clinical Research offer service "AnaCipher CRO services"
Basic Information
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Trade Type
Offer Service
Service Name
AnaCipher CRO services
Details
Specifications
- Trial Phase: Core offering centers on BABE (bioavailability/bioequivalence) studies, a Phase I clinical design conducted in healthy volunteers to support generic and reformulated product approvals.
- Subject Number: BABE studies are typically sized per regulatory guidance for the target market, commonly ranging from roughly 24 to 60 healthy volunteers per study.
- Regulatory Approval: Studies are designed to meet the bioequivalence and safety-reporting requirements of the target regulatory authority, supported by AnaCipher's integrated pharmacovigilance case-processing service.
- Data Management: Study data management is paired with a dedicated medical information call center and individual case safety report (ICSR) processing for ongoing pharmacovigilance needs.
Other Information
Additional Description:
AnaCipher provides end-to-end CRO services including BABE (bioavailability/bioequivalence) studies, a medical information call center, individual case safety reports (ICSR), risk and signal management, periodic safety update reports (PSURs), safety data management, EU/UK Qualified Person for Pharmacovigilance (QPPV) services, legacy data migration, and marketing authorization holder (MAH) support for PV inspections and quality management system setup; it operates from India.
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