Observational Research & Registries

Real-world evidence determines real-world impact

Gathering real world evidence of your product’s value doesn't end at market approval. Quintiles' leading expertise in observational research helps you clearly demonstrate how treatments perform in the real world with patients receiving standard care.

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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 as a standard for required reporting by the Journal of Managed Care and Specialty Pharmacy.

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.

Quintiles Scientific Affairs: The right choice for real-world scientific expertise

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.

The power of possibilities

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.

Related services

Quintiles has provided clinical services to more than 475 real-world and late phase programs since 2011.
Quintiles has access to more than 18M patient lives from hospital data in the COMPASS network.
Quintiles has performed quality measurements for 19 patient associations and medical specialty associations since 2001
Quintiles Expert

Global Chief of Scientific Affairs and Senior Vice President, Real-World & Late Phase Research

Recent thinking: Amazing GRACE

Vice President, Global Head of Risk Management, Real-World & Late Phase Research

Recent thinking: Adaptive pathways offer hope to meeting patients needs faster