Are you adapting your signal management to the changing Pharmacovigilance landscape?
The expectations of signal detection and management by regulatory authorities have become more stringent in recent years.
Having a scalable, systematized and proven signal detection strategy is a vital part of a successful Pharmacovigilance program – regardless of the number of product authorizations your company holds. Each product is unique, therefore the signal strategy should be tailored to fit its safety profile and its current lifecycle stage. It is essential the signal detection strategy be congruent with a clear risk-based signal management plan to allow proper signal validation, prioritization, escalation and timely decision making
Augment your signal detection strategy through our multi-level approach
Ashfield Pharmacovigilance provides signal detection services through a multi-level approach. The first level, or Routine Proactive Signal Detection, provides active signaling at the proposed interval of one-time or per quarter, unless more frequent services are requested. We provide an active signal report that includes tabulations, summaries and analysis reports.
Ashfield Pharmacovigilance provides proactive trending, analysis, and signal management for our clients via our proprietary systems and reports, as well as robust signaling tools. Our vision for signal management is to provide key services and procedures utilizing select tools that assist our clients with early detection of new safety information on their products.
What sets us apart in our signal detection process is the high level review of data by the Safety Evaluation Committee (SEC), which consists of Ashfield Pharmacovigilance’s Chief Compliance and Risk Management Officer, highly experienced safety physicians, pharmacists, benefit-risk management experts, QA team safety scientists and other relevant professionals within the organization. The SEC convenes weekly to review all potential safety signals. These potential safety signals arise from the clinical evaluation of aggregate safety data and individual reports. Based on consensus, Ashfield Pharmacovigilance promptly provides recommendations and confers with our clients on how to best manage potential signals.
Ashfield Pharmacovigilance: Exclusively focused on drug safety
Ashfield Pharmacovigilance effectively operates as an extension of your Pharmacovigilance department — with the same intimate familiarity with your safety data, organizational sensitivities and reporting deadlines. As a domestic company located in Durham, NC’s, Research Triangle Park, Ashfield Pharmacovigilance offers you an alternative to the reservations that come with outsourcing offshore. With over 15 years’ experience, we bring the dedication and skills you need to successfully navigate Pharmacovigilance:
Contact Ashfield Pharmacovigilance to learn more about protecting your product. Please call Trent Wadford at 919-328-5937. Or email firstname.lastname@example.org.
Be proactive about your product’s safety
During the triage stage of case processing one of the client’s dedicated case managers noted an Adverse Event (AE). The Case Manager had seen three (3) cases for this drug with similar events and quickly made the connection that this was a potential signal. The Case Manager escalated this information to ASHFIELD PV’s PV physician, who in turn brought it to the attention of Ashfield Pharmacovigilance ‘s Safety Evaluation Committee (SEC). See Full Case Study
Webinar: Insight into Signal Detection & Management
Signal detection and trending is a powerful method used in the management of drug safety. This webinar focuses on the process of signal detection as detailed in the EMA Guideline on Good Pharmacovigilance Practices (GVP) Module IX – and addresses the recommendations of the FDA.
Click to view our archived webinar!
Full Service or Tailored Signal Detection
Our in-house team of Safety Scientists, MDs, PharmDs and Pharmacoepidemiologists will handled all aspects of your product’s signal requirements, ensuring proactive monitoring and compliance with all government regulations.
Our multi-tier approach offers scalable options, allowing your company to outsource a few or all steps of your signal management process. Our in house experts will work to create a plan that meets your company’s specific needs.
Click to see our full suite of signal detection and management options!