Safety Management Plan
Across all of our clinical development programs, protecting patient safety is critical. From first-in-human trials to post-marketing surveillance, we provide full-spectrum safety monitoring and reporting. With a team of experienced pharmacovigilance professionals, medical monitors, and safety experts, we help Sponsors maintain high standards of safety oversight throughout the clinical trial lifecycle.
Our comprehensive Safety Management services ensure that all safety data is monitored, analyzed, and reported in full compliance with global regulatory requirements. We utilize leading safety databases and AI-driven analytics for efficient signal detection and case processing. Our risk-based approach helps prevent safety issues before they escalate, ensuring smooth trial execution.
Our Comprehensive Safety Management Services include:
Pharmacovigilance & Risk Management
We provide end-to-end pharmacovigilance services, ensuring that safety data is proactively monitored, assessed, and managed in accordance with regulatory guidelines.
Adverse Event (AE) & Serious Adverse Event (SAE)
Handling Our expert team ensures accurate collection, documentation, and reporting of AEs, SAEs, and Suspected Unexpected Serious Adverse Reactions (SUSARs) to regulatory authorities and sponsors.
Safety Data Monitoring & Signal Detection
We implement risk-based safety surveillance to identify safety signals early, ensuring prompt investigation and mitigation of potential risks.
Expedited and Periodic Safety Reporting
We handle all expedited safety reports (e.g., SUSARs, CIOMS, MedWatch) and periodic regulatory submissions, including Development Safety Update Reports (DSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs).
Medical Monitoring & Causality Assessments
Our medical monitors provide real-time safety oversight, conducting causality assessments and ensuring appropriate clinical management of safety concerns.
Safety Database Management & Compliance
We leverage validated safety databases to ensure secure and compliant data management, integrating seamlessly with global pharmacovigilance systems.
Regulatory Compliance & Audit Readiness
Our processes align with ICH-GCP, FDA, EMA, MHRA, PMDA, and WHO pharmacovigilance standards, ensuring regulatory compliance and audit readiness at all times.
Safety Risk Mitigation Strategies
We proactively develop and implement Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) to enhance patient safety and regulatory confidence.