From Adverse Events to Signal Detection and Risk Management
Delivering end-to-end regulatory compliance for patient safety
The increase in reporting of adverse events (AEs), scrutiny by public health policy makers, product recalls due to concerns over benefit-risk and litigations against life science companies are now common. These factors combined with the complexity and rigor of the requirements of global regulatory agencies have resulted in companies paying greater attention to product safety in their pre-market approval process as well as implementing post-marketing risk evaluation and mitigation strategies.
Our comprehensive offerings in Patient Safety include medical contact centers, case processing, reporting of individual safety reports, aggregate safety reporting, signal detection and risk management, and consulting all in support of our clients’ pre-market development and post marketing activities. Risk assessment requires expert judgment combined with input from scientists, clinicians, executives and strategic advisors. Our comprehensive patient safety solutions approach of using the right expertise, process and technology means that decisions are based on superior knowledge, with unwavering attention to maintaining our clients and the public’s trust.
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We provide Patient Safety expertise to support your pre- and post-launch activities in:
For organizations interested in either niche or comprehensive end-to-end PV support, we provide the following Patient Safety capabilities in both pre- and post-launch phases.
Our thought leaders share their insights and opinion on the latest trends, developments and market/regulatory challenges faced by the industry. Read our PV blogs here.
To learn more about our solutions or how we’ve consistently delivered value to our clients, access our case studies and white papers.