Proving value beyond market approval your stakeholders, including regulators, payers, patients and providers, are looking beyond market approval; they want to see that your product can deliver proven, tangible value. Through observational research in real-world settings, you gather the real world evidence needed to develop a robust story of safety, effectiveness and quality to clearly detail your product’s performance, including how it’s helping those who need it most.
The Right Approach for the Right Question®: Generate the evidence you need to demonstrate the value stakeholders demand in the real world
Quintiles brings leading expertise gained from more than 195 observational and real-world research studies, including:
- Patient registries. Collect valuable data about how products perform in real-world conditions.
- Patient-reported outcomes. Support treatment benefits and claims in approved product labeling.
- Safety surveillance/REMS. Track long-term safety outcomes, mitigate risk and monitor off-label use.
- Effectiveness/CER. Demonstrate effectiveness or comparative effectiveness in different populations.
- Health outcomes/Health economics. Support formulary approval or secure favorable reimbursement.
- Retrospective healthcare data. Access electronic healthcare records through our databases and networks.
Through the GRACE (Good Research for Comparative Effectiveness) Initiative, Quintiles led the development of the GRACE checklist. This checklist, based on the GRACE Principles, is designed to guide the assessment of observational studies of comparative effectiveness in terms of their quality and usefulness for decision-making. The GRACE checklist has been formally acknowledged by the National Institute for Health and Care Excellence (NICE) and more recently, taken on as a standard for required reporting by the Journal of Managed Care and Specialty Pharmacy.
Realizing maximum success for your product doesn’t end at market approval. Quintiles will work with you to answer every question completely, accurately and efficiently, from every stakeholder about your product’s real-world impact.