Pharmacovigilance

Pharmacovigilance

We provide flexible, end-to-end pharmacovigilance support for both clinical trials and post marketing programs. Our team ensures compliance with global safety regulations while helping you protect patients and streamline study operations.

Study-Specific Training

Customized training for investigators and site staff on safety reporting.

Safety Reporting Plans

Clear guidance and tools for timely, accurate reporting.

Case Management

Comprehensive handling of ICSRs, coding (MedDRA, WHODD), QC, and medical review.

Safety Database Setup

Secure, study-specific systems for case management and submissions.

Safety Reporting Plans

Clear guidance and tools for timely, accurate reporting.

Case Management

Comprehensive handling of ICSRs, coding (MedDRA, WHODD), QC, and medical review.

Follow-Up & Queries

Efficient resolution of missing data and safety-related questions.

Periodic Safety Reports

Preparation and distribution of safety updates to ECs and investigators.

DSURs & Annual Reports

Development and submission of DSURs and safety reports aligned with global standards.

Expedited Reporting

Regulatory submissions of SUSARs, urgent safety measures, and critical data.

Periodic Safety Reports

Preparation and distribution of safety updates to ECs and investigators.

DSURs & Annual Reports

Development and submission of DSURs and safety reports aligned with global standards.