Many drugs, biologics, and devices in the discovery and development pipeline hold the promise of reducing the impact of chronic health problems in everyday life. But they also represent a significant health care cost, making it incumbent on the industry to document benefits. Similarly, as new treatments are introduced, payors, providers, and most importantly, consumers need to understand their value.

Patient-reported outcomes (PROs) define health benefits more broadly than traditional clinical endpoints and are widely used to support the development, approval and marketing of new drugs and devices. Additional clinical evidence based on PROs also commands the attention of the U.S. Food and Drug Administration (FDA) and other government agencies worldwide, making it critical to the regulatory review process.

QualityMetric measurement scientists have more than three decades of experience in the development and application of generic and disease-specific PRO surveys, with particular reliability and sensitivity to:

• Quantify the consumer’s improved health status
• Proof of efficacy beyond traditional endpoints
• Substantiate product insert and labeling claims
• Raising consumer/clinician disease awareness

QualityMetric PRO surveys are standardized for norm-based comparisons and have been used successfully in over 1300 randomized clinical trials. A number of our most widely used generic surveys (e.g., the SF-36v2™ Health Survey) are linguistically adapted for over 60 languages and are available in multiple modes of administration.

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