Clinical Safety
- Development of Safety Management Plans
- Regulatory Intelligence on Country-Specific Reporting Requirements
- Provision of EudraVigilance (EV) Responsible Person
- Safety Database implementation and validation, safety data migration
- Processing of SAEs, SUSARs and other Reportable Events
- Medical review, assessment and MedDRA coding
- Narrative writing
- Regulatory Reporting (EudraVigilance, US FDA, local authorities)
- Preparation and submission of periodic safety reports
- 50+ Clinical trials managed
- 30+ Safety Management Plans written
- 100% SUSAR and periodic reporting compliance
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What are the benefits of using you as a dedicated pharmacovigilance service provider for Clinical Trial safety instead of a full-service CRO?
Using a dedicated pharmacovigilance (PV) provider offers several key benefits for clinical trial safety services. It allows for expedited reporting of unblinded SUSARs while maintaining study blinding, ensures faster setup of new studies in a single safety database, and centralizes regulatory reporting intelligence across multiple countries and clinical studies. Additionally, a dedicated PV provider can maintain a Master Safety Management Plan (SMP) to streamline trial-specific SMPs and help avoid costly and time-consuming safety data migrations in the future.
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What are the critical steps to consider from a Clinical Safety perspective when planning a clinical trial?
While planning a clinical study, we recommend considering key safety aspects, including preparing a comprehensive Safety Management Plan (covering roles, responsibilities, procedures, and adverse event handling), understanding the regulatory reporting requirements (SUSAR, DSUR) for all countries involved, appointing an EudraVigilance Responsible Person and setting up the Sponsor profile in EudraVigilance, and setting up and validating a safety database. These steps ensure the trial meets regulatory standards and manages safety data effectively throughout the study.
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How do you handle local regulatory reporting requirements for SUSARs and DSURs?
We manage local regulatory reporting requirements for SUSARs and DSURs through dedicated local teams in each country. These teams conduct ongoing regulatory intelligence to keep us and our clients informed of current reporting obligations and deadlines. They also facilitate the submission of SUSAR and DSUR reports to national authorities and ethics committees, ensuring compliance with local regulations and timely reporting across all regions. This approach ensures that all regulatory requirements are met efficiently and accurately.
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What is your experience across therapeutic areas and clinical trial phases?
Our expertise in clinical trial safety management spans multiple therapeutic areas, including oncology, immunology (incl. vaccine trials), urology, respiratory diseases, and other. We are experienced in managing trials across all phases, from Phase 1 to Phase 3, as well as pre-market and post-approval studies. Our team is proficient in various study designs, such as adaptive, open-label, randomized, double-blind, placebo-controlled, and single-arm trials.