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.
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:
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: