Safety Monitoring Continuum
We provide continuous safety oversight across all stages — early-phase, late-phase, and post-marketing. This proactive approach safeguards participants and strengthens regulatory confidence.
We provide continuous safety oversight across all stages — early-phase, late-phase, and post-marketing. This proactive approach safeguards participants and strengthens regulatory confidence.
Our pharmacovigilance services comply with FDA, EMA, CDSCO, ICH, and GCP standards, ensuring seamless global safety management for sponsors operating across regions.
We manage the entire case lifecycle, including
We deploy comprehensive risk management and signal detection strategies, including Risk Evaluation and Mitigation Strategies (REMS), to identify issues early and ensure participant safety.
Beyond case management, our offerings include
Safety database configuration & Safety Management Plan design
Training for site teams on safety reporting
Aggregate safety report preparation (DSURs, PSURs, PBRERs)
Post-marketing pharmacovigilance: literature screening, expedited reporting, database management
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how we can support your next study.