Successful pharmaceutical development—achieving safety results that protect both your investment and your patients—requires astute management of adverse event (AE) monitoring, analysis, and reporting.
Ultimately, the key to reliable Adverse Event Processing is strict adherence to regulatory directives and guidance, consistency of data retrieval and documentation, and the high index of suspicion required to identify and assess critical safety signals.
WCG’s Vigilaire’s seasoned healthcare professionals deliver unmatched expertise in tracking and investigating adverse events. We work with your team to design the systems and processes needed to achieve extraordinary levels of vigilance, as well as documentation you—and regulators—can trust.
Among Adverse Event service providers, only WCG Vigilaire focuses exclusively on pharmacovigilance. As such, we strengthen your AE processing with breadth, depth, and discernment across the entire scope of product safety.
Because WCG Vigilaire also provides Quality Assurance, Risk Management, Medical Information, and Product Contact solutions, our Adverse Event Processing services deliver the added value of astute product safety intelligence.
Our leadership team lends more than 45 years of pharmacovigilance experience to ensure your product’s success. We’ve handled millions of adverse events, managed dozens of regulatory audits, and developed Adverse Event solutions for nearly every class of pharmaceutical product. It’s why scores of top pharmaceutical brands have relied on us to guide hundreds of best-selling medicines to market.
WCG’s Safety Portal not only streamlines distribution, but also ensures that only those who need to see any given document receive it. This efficiency reduces wasted time and expense, and it improves site response to safety notices.
In short, Safety Portal resolves nearly every obstacle to efficient safety document distribution, while protecting patients with up-to-the-minute safety guidance.
Learn more about the WCG Safety Portal
Safety Portal helps sponsors and CROs categorize safety reports granularly, so they’re matched precisely to recipients’ need-to-know.
Monitor global regulations in real time
WCG’s Safety Portal permits automated, continuous monitoring of regulatory distribution requirements for 110 countries, so you’re always compliant for every site.
Safety document distribution is immediate, secure and cost-effective. And, it all happens within a tight, trackable system allows you to monitor distribution instantly, and remain audit-ready day and night.
Reports and Submissions
Provision of a Safety Database
Oversight and Management
The key to successful pharmacovigilance programs is treating product inquiries and complaints as early-warning safety intelligence. By understanding the sometimes-obscure nature and pattern of these inquiries, Vigilare helps pharmaceutical companies not only to respond promptly and appropriately to individual queries, but also to prepare for and manage deviations of greater scope. It is through this expertise that we help clients recognize inquiry trends early, so they’re able to respond definitively and with discernment—before issues expand into broader safety concerns.
A short conversation should help assess your need and how WCG can assist. To arrange a call with one of our principals, simply fill out the form.