A successful study design demonstrates product value while providing RWE to meet regulatory and payer needs and improving patient outcomes.
Partner with us to identify and generate the evidence needed to support your design.
Determining what evidence is needed and the most efficient ways to generate it is key to designing studies that meet regulatory and payer expectations. Navigate the path to regulatory acceptance with:
IQVIA offers 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 and are active partners and participants with OMOP, ENCePP, EUnetHTA, IMI, the Department of Health and Human Services and others.
Access a wide spectrum of data and sourcing approaches from existing secondary data, primary data, registry collaborations, and patient reported outcomes.
Connecting with existing real world data sources helps identify the right patients and facilitate recruitment.
IQVIA is the leader in creating study efficiencies with innovative approaches
Source: As determined by independent research on RWE/Medical Affairs Market landscape
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.
Provide context for single-arm trials using real world data, increase operational efficiencies and meet Regulator and Payer requirements with confidence.
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.
Generate Real World Evidence to evaluate the effectiveness of a randomized intervention in real-life conditions, helping you answer Regulator and Payer questions about your product.
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