Total Safety Solution

WCG's end-to-end safety solution is purpose built safety solution designed to relieve the burden of small and emerging biotech managing global drug safety and safety reporting operations.

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An Intelligent Safety Solution Proven to Reduce Risk and Alleviate Site Burden

We created our end-to-end safety solution with and for emerging biopharma companies. WCG provides turnkey drug safety and pharmacovigilance processes, expertise, U.S. based dedicated safety teams, and proprietary drug safety technologies.

WCG’s Safety Solutions helps clients avoid building infrastructure and eliminates your need for capital investment in internal IT software and systems. It’s a cost efficient operational model as an extension of your client team, allowing you to reduce the number of internal safety specialists and annual overhead costs required to meet demand peaks and reduce burden on sites to review safety documents. In addition, all safety data is collected from global investigator sites and CRO’s into a single safety database, in real time, saving valuable time and significant expense.

“We engaged WCG in 2017 to develop an enterprise approach to safety letter delivery for increased compliance while simultaneously reducing the amount of administrative burden facing the Pharmacovigilance team. The results have been significant: enterprise compliance increased from 30% to 92% within 18 months.” —VP, Top Pharma Client

125 country regulations supported
$40k per study saved on average
90% reduction in site burden

Three Services Aligned for a Total Safety Solution

 

Case Processing and Aggregate Reporting

WCG provides a U.S. based team of dedicated and experienced drug safety professionals to:

1. Setup and manage a hosted instance of ARGUS.
2. Provide high-quality case processing, narrative writing, case management, and medical review services that can be relied upon not to require regular re-work
3. Perform Global Safety Reporting to Investigators, Ethics Committees, and Health Authorities using WCG’s proprietary global safety reporting regulatory intelligence
4. Offer a flexible workflow tailored to each client’s desired drug safety and PV operations function

Proven Global Safety Reporting Regulatory Intelligence

WCG provides the industry best practice interpretation and operationalization of global safety reporting requirements for over 125 countries to our customers. We provide this not by providing the raw regulatory intelligence, but by harmonizing the industry’s best practice interpretation of that intelligence and providing a “reference model” for our customers to follow – used and relied upon by the largest biopharma companies. This helps eliminate over-reporting, manual regulation tracking, and ensure inspection readiness. In short – it saves time, cost, and resources while ensuring the best compliance and the least site burden.

Safety Letter Distribution

WCG’s safety letter distribution allows biopharma companies and CROs to notify investigators and ethics committees of Suspected Unexpected Serious Adverse Reaction (SUSARs) in a globally compliant, centralized, and automated process. Our precision safety reporting automatically pinpoints which stakeholders need to receive each safety document, eliminating overdistribution and keeping every study inspection ready 24/7. By integrating into your safety database, CTMS, or eTMF, we help to create a proven automated distribution business process proven at the largest pharma companies.

Benefits to our Clients:

Eliminate Overdistribution

Reduce Site Burden

Achieve Quality and Compliance

Patient Safety

Risk Management

Impactful ROI

Schedule a demo of WCG's Total Safety Solution

See how you can relieve the burden of your drug safety and safety reporting operations through WCG’s Total Safety Solution. Complete the form to get started.