Innovative benefit risk management plan to meet requirements and add value
You work every day to address changing regulatory requirements. With the right partner offering the right approach, you can develop an innovative benefit risk management plan that can meet these requirements, and also deliver cost-effective, value-added tools for monitoring and measuring the benefit-risk profile of your products.
Change your approach and exceed expectations
Regulatory agencies are increasingly looking at safety through the lens of benefit-risk balance, so we continually align our approach to theirs. Our capabilities do not reside in a siloed REMS/RMP department, but in a Global Benefit-Risk Management (GBRM) Center where we leverage dedicated safety and real-world late phase resources.
The Quintiles GBRM Center collaborates with customers to:
- Establish current disease burden through primary and secondary research.
- Determine and understand the drivers of patient and prescriber behaviors.
- Uncover the knowledge and attitudes of patients, caregivers and healthcare providers.
- Build safety program materials that deliver information as well as the engagement/motivation requisite for participation in voluntary programs.
- Notify stakeholders of a safety initiative through multiple channels, including advertising in professional journals.
- Develop, pilot test, refine and field Knowledge, Attitude and Behavior (KAB) surveys.
- Design world-class benefit-risk registries to track the success of your benefit-risk program via outcome indicators as well as process indicators.
- Participate in the regulatory discussions shaping the future of safety/benefit-risk management.
Specialized benefit-risk approach: Quintiles' strategies and data-driven safety and risk minimization programs demonstrate or enhance appropriate and safe use of drugs, biologics and devices. Multi-tiered programs range from education and behavior evaluation to post-authorization safety studies (PASS), and safety registries to performance-linked and controlled access programs.
Global and local operational and regulatory expertise: With over 36,000 employees in more than 100 countries, Quintiles has extensive global reach. We have the insight to apply local solutions and the depth and breadth of knowledge to help mitigate risk and maximize global markets.
Deep therapeutic insights: More effective and specialized programs along with a greater understanding of risks are possible with the expertise of Quintiles’ more than 1,050 PhDs, 1,100 medical doctors and 14 therapeutic centers of excellence.
Our EHR database and the Quintiles COMPASS Distributed Data Network now give you access to millions of de-identified electronic health records with links to prescription, lab and administrative data. We then integrate this information using targeted electronic data record (EDC) systems for near-real time analysis, so you can achieve quicker data insights and generate a patient baseline for prospective studies.
Collaborative partnerships for the future: Reflecting our deep methodological expertise and interest in shaping the future of safety and risk management, Quintiles participates in a number of collaborative initiatives, including the European Medicine Agency’s PROTECT-EU and ENCePP projects, EPAD and the US FDA’s Sentinel Initiative.
As partners, Quintiles works with you to enhance the success of your product and influence the future of safety and risk management.