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 serious adverse event (SAE) and serious unanticipated device effect operations, analysis, and reporting.

Ultimately, the key to reliable Event Processing is strict adherence to regulatory directives and guidance, consistency of data standards, retrieval and reporting, and the high index of suspicion required to identify and assess critical safety signals.

WCG’s seasoned healthcare professionals deliver unmatched expertise in tracking and investigating serious safety reports. 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.

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

Among safety reporting service providers, only WCG focuses exclusively on safety event management, working with you to build the safety profile of your product by managing the SAEs and other types of serious safety reports directly from clinical studies into one safety system. As such, we strengthen your safety processing with breadth, depth, and discernment across the entire scope of product safety.

Because WCG also provides Quality Assurance, Risk Management, Medical Information, and Product Reporting solutions, our Event Processing services deliver the added value of astute product safety intelligence.

Our leadership team lends more than 50 years of product vigilance experience to ensure your product’s success.  We’ve handled millions of safety events, managed dozens of regulatory audits, and developed safety solutions for nearly every class of pharmaceutical device or vaccine product. It’s why scores of top medicinal product brands have relied on us to guide hundreds of best-selling medicines to market.

Our Safety Reporting Solutions automate document distribution, improving speed, accuracy, and patient safety.

WCG’s Safety Reporting Solutions not only streamline distribution, but also ensure 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, our Safety Reporting Solutions resolve nearly every obstacle to efficient safety document distribution, while protecting patients with up-to-the-minute safety guidance.

Learn more about WCG’s Safety Reporting Solutions

Rely on WCG for all drug safety needs

Case Processing

  • Clinical trial safety report 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) for US SUSAR reporting
  • SUSAR report preparation and communication to:
    • Health Authorities, Investigators, clinical CROs or sponsor staff

Reports and Submissions

  • Submission-ready individual case safety reports for health authorities
  • Provision of line listings for database reconciliation 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 for each client

Oversight, Management, and Consulting

  • 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 safety management programs is achieved by working with our clients to build the safety profile of their product, looking at the safety reporting the same way with consistent data standards for data entry and analysis by healthcare professionals and by providing consolidated data for expert review. Our safety staff are expert in reviewing safety data from a regulatory perspective to ensure correct reporting and to keep patients safe.

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.