Explore IQVIA by region
As a global community, IQVIA continuously invests and commits to advancing human health.
Europe
Asia & Oceania
Middle East & Africa
EMEA Thought Leadership
SOLUTIONS
Research & Development
Real World Evidence
Commercialization
Safety & Regulatory Compliance
Technologies
LIFE SCIENCE SEGMENTS
Pharmaceutical Manufacturers
Emerging Biopharma
Consumer Health
MedTech
Generics
HEALTHCARE SEGMENTS
Information Partner Services
Financial Institutions
Public Health and Government
Patient Associations
Payers
Providers
THERAPEUTIC AREAS
Cardiovascular
Cell and Gene Therapy
Central Nervous System
GI & Hepatology
Infectious Diseases and Vaccines
Oncology
Pediatrics
Rare Diseases
View All
Impacting People's Lives
Harness the power to transform clinical development
Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
Research & Development Overview
Real World Evidence. Real Confidence. Real Results.
Generate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.
REAL WORLD EVIDENCE OVERVIEW
Real World & Health Data Sets
Real World & Health Data Sets (desc)
Medical Affairs
Medical Affairs (desc)
Health Data Apps & AI
Health Data Apps & AI (desc)
Health Data Transformation
Health Data Transformation (desc)
Study Design
Study Design (desc)
Evidence Networks
Evidence Networks (desc)
Health Economics & Value
Health Economics & Value (desc)
Regulatory and Safety
Regulatory and Safety (desc)
Natural Language Processing
Natural Language Processing (desc)
Real World Evidence Library
Real World Evidence Library (desc)
See markets more clearly. Opportunities more often.
Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.
COMMERCIALIZATION OVERVIEW
COVID-19 & Commercialization
COVID-19 & Commercialization (desc)
Launch Strategy & Management
Launch Strategy & Management (desc)
Brand Strategy & Management
Brand Strategy & Management (desc)
Pricing & Market Access
Pricing & Market Access (desc)
Healthcare Professional Engagement
Healthcare Professional Engagement (desc)
Patient Engagement
Patient Engagement (desc)
Promotional Strategy
Promotional Strategy (desc)
Service driven. Tech-enabled. Integrated compliance.
Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
COMPLIANCE OVERVIEW
Intelligence that transforms life sciences end-to-end.
When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.
TECHNOLOGIES OVERVIEW
Orchestrated Clinical Trials
Orchestrated Clinical Trials (desc)
Enterprise Information Management
Enterprise Information Management (desc)
Performance Management & Insights
Performance Management & Insights (desc)
Provider Reference Data Network
Provider Reference Data Network (desc)
Customer Engagement
Customer Engagement (desc)
Safety, Regulatory, Quality Compliance
Safety, Regulatory, Quality Compliance (desc)
Developer
Developer (desc)
Partner Programs
Partner Programs (desc)
Technology Insights
Technology Insights (desc)
The IQVIA difference
CLINICAL PRODUCTS
Planning Suite
Site Suite
Patient Engagement Suite
Trial Management Suite
Clinical Data Analytics Suite
COMMERCIAL PRODUCTS
Information Management
Launch Strategy & Management
Performance Management & Insights
Brand Strategy & Management
Customer Engagement
Pricing & Market Access
COMPLIANCE, SAFETY, REG PRODUCTS
Commercial Compliance
Regulatory Compliance
Quality Compliance
Safety & Pharmacovigilance
REAL WORLD PRODUCTS
Data Profiling
Patient Profiling
HCP Profiling
Market Profiling
Health Data Transformation
Natural Language Processing
CASE STUDY
Explore IQVIA by region
As a global community, IQVIA continuously invests and commits to advancing human health.
Americas
Europe
Asia & Oceania
Middle East & Africa
EMEA Thought Leadership
White Paper
Our Perspectives on the US FDA Patient-Focused Drug Development (PFDD) Guidance 3 and 4
Integrating patient experience data into endpoints to inform a COA endpoint strategy
Dec 02, 2020
- Library
- Our Perspectives on the US FDA Patient-Focused Drug Development (PFDD) Guidance 3 and 4
Get instant access
The FDA is currently developing a series of four Patient-Focused Drug Development (PFDD) Guidance Documents for the healthcare industry. This insight brief outlines PFDD Guidance 3 and 4, which focuses on COAs adequacy to measure those essential concepts in a clinical trial, and to endpoint development and how COA information can be used to inform regulatory decision-making.