Regulatory Science Series

Innovative evidence generation for regulatory decision making

The Regulatory Science Series shares ongoing efforts at IQVIA to develop and utilize innovative approaches to assess the performance of regulated products. They feature details on case examples and lessons learned in advancing novel use of real world data, real world evidence, clinical trial design, digital health technologies, drug safety, and post-market surveillance to help bring regulated products to market.

Practical Insights for Cell and Gene Therapy Long-term Follow-up Studies

Helping regulators develop new tools, standards, and approaches for assessing the safety, efficacy, quality, and performance of regulated medical products.

Expanding Access to Home-Use Medical Technologies

Expanding access to home-use technologies can help bridge the healthcare gap and advance health equity. However, there are challenges and opportunities associated with developing, evaluating, and monitoring home-use technologies, such as ensuring usability, reliability, connectivity, security, privacy, and patient safety.

Spurring Clinical Trial Innovations: Overcoming Barriers to Adoption

The adoption of risk-based monitoring and innovative trial designs has shown significant progress. There are clear opportunities to expedite patient-centric drug development and decentralized data gathering, as well as to integrate real-world evidence as substantial proof of effectiveness in premarket submissions.

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