Drug Safety and Pharmacovigilance

Patient safety is paramount throughout a product’s life cycle – from drug development to post-approval.

We offer the full suite of pharmacovigilance services to ensure regulatory compliance and patient safety during the whole drug development process. With quality driven processes and comprehensive and flexible solutions, we ensure the active management of drug safety and pharmacovigilance. Our services can be individually tailored to the requirements of the product and company, delivering cost-effective safety that matches your requirements.

Our safety and pharmacovigilance team comprises multilingual MDs, PhDs and pharmaceutical scientists with broad therapeutic expertise. They operate in accordance with current regulatory requirements, ensuring business continuity and in-time safety reporting.

Pharmacovigilance solutions include the management of individual case safety reports (ICSRs) using the Oracle Argus system as a central safety database. Additional services include literature searches (Elsevier Embase) and input to signal detection.

Our expert safety writers can deliver:

• Development safety update reports (DSUR)
• Periodic safety update reports (PSUR)
• Periodic adverse drug experience report (PADER/PAER)
• Periodic benefit-risk evaluation report (PBRER)
• Safety summaries
• Benefit/risk assessments
• Clinical overviews

With up-to-date knowledge of country specific safety reporting requirements, we ensure compliance with on time submission of safety reports to health authorities, ethics committees and other stakeholders.

We are recognized as the benchmark for quality and integrity in clinical trials. Whatever your requirements, we have the expertise in drug safety and pharmacovigilance to help you ensure the safety of your patients.