Drug Safety & Pharmacovigilance Services

Quality First

Our drug safety philosophy is characterized by a documented process rooted in sound clinical knowledge, adherence to good pharmacovigilance practice and supported by comprehensive clinical development expertise ― built on a mature global footprint.

Innovative Operational Approach

Serious adverse events (SAE) reports from all over the world (including the Pacific Rim and South America) are directed into one of Worldwide Clinical Trials’ global Medical and Safety hubs: Morrisville, NC, United States, (Western hemisphere), and Nottingham, UK, (western half of the Eastern hemisphere). Cases are then electronically entered, managed and stored within our Argus™ Safety Database.

Our team effectively manages SAEs regardless of where they occur in the world, in a time-sensitive and regulatory-compliant manner.

Drug Safety services for Phase I-III development include:

• SAE reporting
• SAE processing
• Narrative writing
• Medical review
• Lab and diagnostics test review
• Safety report distribution and submission
• Argus™ Safety Database
• Expertise in all major systems (ARISg, Oracle AERS)
• On-site training in pharmacovigilance and risk management

Pharmacovigilance and Peri-Approval

We reinforce our peri-approval services with periodic aggregate reports, trending analysis and ad hoc safety signal analyses, in addition to the review of solicited and spontaneously reported adverse drug reaction case data.

We also serve as the safety department for companies lacking their own in-house resources and confidently manage the transition of medicines in clinical development to marketed products.

Safety services for marketed products include:

• Post-marketing surveillance
• SADR, spontaneous ADR processing and reporting
• Serious adverse event (SAE) processing and reporting
• Registries, phase IV trials
• Lab and diagnostic test review
• Periodic safety update reports (PSUR), annual and quarterly report preparation
• Signal detection services
• Trending analyses for labeling changes
• Argus™ safety database
• REMS/RMP design and advisory consultation