Drug Safety

Protect patients and trials with disciplined Drug Safety processes you trust

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.

Adverse Event Processing by WCG: People, processes, and systems that ensure reliability

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.

Safety Portal automates document distribution, improving speed, accuracy, and patient safety.

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

Eliminate waste

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.

Accountable processes

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.

Rely on WCG for all drug safety needs

Case Processing

  • Clinical trial SAE receipt, review, assessment and follow-up
  • Medical coding, narrative writing and follow-up
  • Medical review, quality control and query resolution
  • Analysis of Similar Events (AOSE)
  • SUSAR report preparation and communication to:
  • Investigators and Health Authorities; clinical CROs or sponsor staff

Reports and Submissions

  • Submission-ready individual reports for health authorities
  • Provision of listings for database reconciliation and study line listings with Data Management Plan
  • Aggregate report preparation DSUR/IND Annual Reports
  • Management of compliance and performance metrics

Provision of a Safety Database

  • Setup and configuration of a commercially available, fully validated safety database

Oversight and Management

  • Provide expertise and domain knowledge
  • Project-specific issue management
  • Product review activities (if required by HA or for proactive risk management)
  • Quality Assurance including retrospective review of reports
  • Case processing metrics review

WCG Drug Safety is powered by Vigilare

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.

Scientific Review Resources from WCG

The map below displays WCG locations. The same locations are listed below the map.

Let’s discuss your Drug Safety requirements

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.