Study Design

Find the right study design.

Ensure your study demonstrates your product's value and drives better patient outcomes.  We will help you design the right study for your needs.

Smarter ways to generate evidence

The increasing costs of developing treatments requires smarter approaches. Access a wide spectrum of data and sourcing approaches from existing secondary data, primary data, registry collaborations, and patient reported outcomes.

Every study is different. Tap into our fit-for-purpose study designs. The IQVIA CORE supports specific research needs built on our domain expertise, unparalleled data, transformative technology and advanced analytics. 

IQVIA is the perceived RWE market thought leader and expert across RWD sources and proper use, RWD analytical capabilities and RWE generation – by a significant margin.
Source - Life Science Strategy Group, LLC – Real World Evidence Report 
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Smarter study approaches

We are reimagining evidence generation with innovative approaches you can leverage right now, today.  

  • Enriched Study Methodology: Integrate secondary data from non-identified databases (such as EMRs, Claims, Research cohorts) with primary data from physicians and patients to build a comprehensive patient record specific to your research. Learn more here.
  • External Comparator Studies: Provide context for single-arm trials using real world data, increase operational efficiencies and answer Regulators’ and Payors’ requirements with confidence. 
  • Extension Studies: Meet additional research objectives by keeping patients and investigators engaged post-trial. Drive efficiencies and capture long-term patient outcomes to understand the long-term safety and effectiveness of your drug. Learn more here.
  • Pragmatic Trials: Generate Real World Evidence to evaluate the effectiveness of a randomized intervention in real-life conditions, helping you answer Regulators’ and Payers questions on your product.

Accelerated recruitment

By connecting with existing real world data sources, we can more easily find the right patients and quickly move to recruitment.

Pure Primary: Randomized Clinical Trials and Prospective research. Expand your study options: extension studies, direct-to-patient studies, enriched studies, pragmatic trials, external comparators. Pure Secondary: Database studies.
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Regulatory knowledge

One potential challenge of new study designs is regulatory acceptance. IQVIA brings a history of EMA-accepted Drug Utilization Studies (DUS) in multiple therapy areas and geographies and extensive experience working with the FDA, ENCePP, EUnetHTA , MHRA.

Current working knowledge helps ensure that your studies meet regulatory standards. As active partners and participants with OMOP, ENCePP, EUnetHTA, IMI, the Department of Health and Human Services and others, IQVIA is committed to remaining current for the benefit of our customers.

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