Oversight & Safety

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An Intelligent Safety Solution Proven to Reduce Costs & Risk

WCG’s Oversight & Safety solution is an integrated safety solution that allows your team faster, higher-quality access to safety data and processes, while freeing up both your capital and your staff to focus on in-depth product safety analysis.

The service is provided by our team of experts, with decades of experience managing safety programs for multinational biopharmaceutical companies requiring the annual processing of thousands of reported adverse events. These industry-recognized experts are supported by experienced safety healthcare professionals with a unique combination of global safety, pharmacovigilance, risk management and therapeutic area expertise.

Our integrated teams provide end-to-end safety services of the highest standard to meet demanding regulatory deadlines and compliance for adverse event processing and submission.

increase compliance and improve patient safety
get better visibility into your product safety data
backed by a team of safety experts

Three Services aligned for a complete Oversight & Safety Solution

Total Product Safety Management

We create a safety management plan to ensure that all aspects of the scope of work are clearly defined. The set-up and configuration of a single integrated safety database across all of your development programs in order to reduce wasted time and expense, and improve site response to safety notices is done through our adverse event database.

WCG delivers unmatched expertise in tracking and investigating adverse events all the way through submission. 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.

Expert Committee Review

As an industry leader in EAC and DMC management, WCG brings clients the largest committee dedicated staff in the industry, our own global network of more than 600 vetted medical experts who can serve as committee members or expert advisors to clients, and a proprietary technology platform that provides user-friendly data packages and streamlined operations for effective decision-making.

Having experts outside of a company’s ecosystem as active partners can lead to better defined data gathering, earlier risk signal detection, peeks into competitive advantages and ultimately a value enhanced, streamlined approach to leveraging intelligence gathered from clinical trials.

 

Precision Safety Reporting

Our precision safety reporting automatically pinpoints which stakeholders need to receive each safety document, eliminating over-distribution 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.

Our precision safety reporting offers the only global safety reporting solution that has been demonstrated to increase compliance and improve patient safety, while reducing cost and streamlining operations.

Oversight & Safety is powered by WCG SafetyPortal™

SafetyPortal provides global safety document distribution with real-time delivery, automated viewer tracking and robust reporting capabilities.

SafetyPortal not only streamlines safety report distribution, but also ensures that only those who need to see any given document receive it, reducing wasted time and expense.

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Advantages for the Emerging Biopharma Enterprise

We created a purpose built complete safety solution for emerging biopharma with turnkey pharmacovigilance processes and systems.

WCG’s Safety & Oversight solution eliminates your need for capital investment in internal IT software and systems for trial safety processes. You can also reduce the number of internal safety specialists and annual overhead costs required to meet demand peaks.

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.

See how Oversight & Safety can help you overcome all your safety challenges

Complete the form to request a schedule a consultation with WCG. We’ll demo the solution, help assess your need, and how WCG can assist.