Pharmacovigilance in clinical trials
Smooth Drug Development provides services of pharmacovigilance in clinical trials.
Pharmacovigilance during the clinical development of pharmaceutical product is a collection of safety information, analysis, and reporting to the competent authorities and all relevant parties.
Information gathering and distribution is performed centrally for all trials conducted with the product. This means that in case of a new safety information available in one study, the new data will be received at all sites and regulatory authorities in all studies with this drug.
Pharmacovigilance is performed in accordance with the Pharmacovigilance plan, which contains information about the safety of the drug and the expected adverse events, criteria for evaluating of the relationship to investigational product, timelines of reporting of serious adverse events and unexpected reactions (SAE and SUSAR), reporting procedures on special events, project-specific forms and instructions for all countries in the study.
Our company performs pharmacovigilance in accordance with the recommendations of the guidelines ICH E2A "Clinical Safety Data Management: Definitions and Standards for Expedited Reporting", E2F "Development Safety Update Report", and local regulations.
Pharmacovigilance in the study include:
- Development of Pharmacovigilance plan
- Development of project-specific reporting forms
- Preparation and review of SAE reports
- Preparation of express and regular reports, their submission to the regulatory authorities and distribution to study sites