A pharmacovigilance service is the fourth most important part of product life cycle. Pharmacovigilance is now utmost important in almost all countries of the world to take care patient first and then product life cycle. Our team is dedicated medical expertise to provide you with a flexible Pharmacovigilance solution tailored to your needs. AstraClinical proposes an organizational structure that ensures the most efficient work-flow and processes. 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).

We can support in compiling Pharmacovigilance System Master File (PSMF), Drug Safety Database System Set up and implementation along with audit and training.

AstraClinical Pharmacovigilance team 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
  • Expedited reporting of SAEs
  • AE and SAE logging, tracking, MedDRA and WHO-DD coding, case processing and distribution to stakeholders
  • Individual case safety reports (ICSR)
  • Aggregate report writing
  • Periodic safety updates Report (PSUR)
  • Development safety update reports (DSUR)
  • Risk Management Planning (RMP)
  • Periodic Benefit Risk Evaluation Report (PBRER)
  • Periodic Adverse Drug Experience Report (PADER)
  • Concise safety analysis and benefit-risk evaluation
  • Annual safety reports or clinical safety reports
• Risk evaluation and mitigation strategies
• 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.
• AstraClinical Pharmacovigilance provides you with a continuous monitoring and evaluation of potential safety issues for signal detection and Risk-Benefit assessments. AstraClinical 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.
• Training: We provide training to client to understand pharmacovigilance system and to face pharmacovigilance audit by the regulatory agencies. We also train client to conduct inspection and audit within the organization and distributors. We train client as how to develop contract with buyers and vendors including distributors.