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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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Americas
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Asia & Oceania
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Europe
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Middle East & Africa
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Americas
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Asia & Oceania
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Europe
Europe
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
WHO WE HELP
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Pharmaceutical Manufacturers
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Pharmaceutical Manufacturers
Harness unparalleled healthcare data, advanced analytics, and cutting-edge technologies with our expertise to accelerate the development and commercialization of innovative medicines, enhancing patient lives.
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Emerging Biopharma (Global page)
Boost your innovation with IQVIA's expert team. Our comprehensive solutions integrate top-tier insights, technology, and expertise to maximize your asset's success in a competitive landscape.
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Navigating MedTech's unique landscape: U.S. decision-making now rests with GPOs, IDNs, and payers, who demand solid value proof through rigorous outcomes analyses and pricing scrutiny.
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Financial Institutions
Invest in healthcare with confidence. Stay ahead of pharma and medical device trends using real-time, high-quality data. Access market insights, historical sales, prescription trends, and emerging product information for informed, risk-reduced decisions.
Access InsightsGovernment and Public Health
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Health Plans
Accelerate digital innovation with our data-driven expertise in data science and healthcare, optimizing business processes for smarter decisions.
Navigate Health PlansHospital and Health Systems
Leverage digital innovation to cut costs, boost efficiency, and elevate patient engagement, all while enhancing quality and health outcomes.
Streamline DecisionsHospital and Health Systems
Insurers and Risk
Enhance your ability to evaluate and forecast population risk swiftly and accurately by integrating unmatched data, expertise, and technology.
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Medical Specialties and Patient Organizations
Embrace digital innovation in healthcare to make more informed decisions and advance your mission as a data-driven organization.
Explore NowU.S. PROGRESS POINT
A curation of IQVIA's best thinking on topics and trends driving change, disruption, and progress in the United States healthcare market.
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Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.
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EXPLORE PODCASTSCase Study
Accelerating Software Approval Through FDA's ISTAND Pilot Program
Apr 25, 2025
In a recent project, a customer developed innovative software designed to address an unmet need in evidence generation. The software had the potential to revolutionize the way data was collected and analyzed, offering new insights and improving decision-making processes in the healthcare industry. However, to bring this groundbreaking software to market, the customer needed to navigate the complex regulatory landscape and gain FDA approval.
The customer faced the challenge of securing FDA approval for its innovative software. This approval was crucial for the software to be recognized and trusted by healthcare providers and stakeholders. The customer sought to leverage the FDA's ISTAND (Innovative Science and Technology Approaches for New Drugs) pilot program, which supports the development of novel Drug Development Tools (DDTs) that fall outside the scope of existing qualification programs. The ISTAND program aims to facilitate the regulatory acceptance of innovative approaches that can enhance drug development and regulatory review processes.
Learn how IQVIA's pioneering approach provided the customer with access to additional FDA support and significantly accelerated the review timelines, enabling a faster path to market.
The customer faced the challenge of securing FDA approval for its innovative software. This approval was crucial for the software to be recognized and trusted by healthcare providers and stakeholders. The customer sought to leverage the FDA's ISTAND (Innovative Science and Technology Approaches for New Drugs) pilot program, which supports the development of novel Drug Development Tools (DDTs) that fall outside the scope of existing qualification programs. The ISTAND program aims to facilitate the regulatory acceptance of innovative approaches that can enhance drug development and regulatory review processes.
Learn how IQVIA's pioneering approach provided the customer with access to additional FDA support and significantly accelerated the review timelines, enabling a faster path to market.
Related solutions
Regulatory and Safety
From concept to market, we can meet your ever-increasing needs in regulatory, safety and compliance.