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 can develop a robust story of safety, effectiveness and quality that clearly details 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 175 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.
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.