Pharmacovigilance and Drug Safety Expertise

At Anovus Clinical Research our Pharmacovigilance and Drug Safety group is dedicated solely to collecting, interpreting and reporting safety events on behalf of clients after their products are approved for marketing, covering a broad spectrum of therapeutic areas. Our services span the life cycle of marketed medical products, including pharmaceuticals, biologics and medical devices.

Adverse Event Processing and Reporting

MedDRA and WHODrug Coding
Narrative Writing
Quality Control
Medical Review
Reporting to Health Authorities and Stakeholders
Signal Detection, Analysis and Submission

Development of Safety Reports

Indivisual Case Study Reports (ICSR)
Periodic Safety Update Reports (PSUR)
Periodic Adverse Drug Experiences Reports (PADER)
Development Safety Update Reports (DSUR)
Annual Safety Reports (ASR)

Site Management    Medical Writing    CDM   Statistical Analysis    Pharmacovigilance   CDISC   Regulatory Affairs

Copyright ©, 2010 All rights reserved