Linical Co.,Ltd.

Pharmacovigilance

Pharmacovigilance

The Linical Pharmacovigilance team offers the regulatory knowledge and dedicated medical expertise to provide you with a flexible Pharmacovigilance solution tailored to your needs. Linical proposes an organizational structure that ensures the most efficient work-flow and processes.

Linical Pharmacovigilance can work as an extended arm to your safety department, or as your external pharmacovigilance team, on a study, program or company level, offering the following services for Investigational Medicinal Products and Medicinal Devices, both during clinical development and post-authorization.

• A fully ICH and FDA 21 CFR part 11 compliant and validated Oracle AERS 4.7 safety database is used. The Set-up and maintenance of the safety database is provided. MedDRA coding and SAE Reconciliation services are included.
• Our Pharmacovigilance system is based on the latest updates of the EMA 2012 Good Clinical Pharmacovigilance Practices. Consistent procedures ensure highest quality standards.
• Safety and Medical Management Plan is customized to your study and make sure that all safety issues are covered.
• Processing of adverse events (AE) and adverse drug reactions (ADR) during clinical trials and post-authorization. Collection, assessment of seriousness, expectedness and causality, medical evaluation of Pharmacovigilance data, Cases data entry and quality control, Patient narratives.
• Development and submission of ICSRs and periodic reports (Periodic Safety Update Reports (PSUR)/Development Safety Updates Reports (DSUR), and other ad-hoc reports), US periodic reports (Annual Safety Reports).
• All our Pharmacovigilance officers are EudraVigilance certified. We have experience in EudraVigilance registration of Sponsors and users, expedited reporting of ICSRs and SUSARs to EudraVigilance and national portals, submission of products to extended Medicinal Product Dictionary (XEVMPD).
• Linical Pharmacovigilance provides you with a continuous monitoring and evaluation of potential safety issues for signal detection and Risk-Benefit assessments. Linical offers extended medical support to sites to the study team.
• Qualified Person for Pharmacovigilance for Europe and local Qualified Person are included in our organizational structure.