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One of your top priorities is ensuring safety for every product you manufacture and every clinical trial you run. You can count on the Medical Vigilance Solutions pharmacovigilance team to help you achieve that goal with reliable, accurate safety surveillance from phase 1 clinical trials to the post-market arena.
Our highly trained pharmacists, nurses and allied health professionals provide comprehensive pharmacovigilance for drugs and devices, biologics and consumer product goods. These healthcare professionals expertly handle all aspects of case processing activities, from adverse event intake and assessment/triage to data entry, narrative writing and coding, through follow-up and medical and quality reviews.
Pharmacovigilance team members use a validated safety database and provide database reconciliation using our internal ArisGlobal database or client platforms, such as ARGUS and Rave. Our seasoned professionals have industry experience and deep therapeutic expertise in many medical subspecialty areas, including:
You create the pharmacovigilance package your company needs, selecting from our comprehensive suite of outsourcing services:
On-time, accurate reporting to national and global agencies, including aggregate, periodic and expedited regulatory reporting (PSUR, PADER, etc.)
Data analysis and signal detection
Regulatory agency pharmacovigilance audit support (PV auditing)
Surveillance and analysis of global medical literature
Specialized clinical trial services, including MedDRA and WHODrug coding
Pharmacovigilance risk management services for high-risk pharmaceutical drugs