Post-Marketing Safety Studies

Patient safety is always the first priority.
A well-planned post-marketing safety strategy can make all the difference.

Advances in science, technology, and the availability of real-world data have led to a new and rapidly evolving global safety landscape for medical products. This means companies are faced with an increasing number of assets requiring post-authorization safety studies and the need to respond as efficiently as possible to ensure the safety of their products while continuing to maximize patient access.

Connect with One of Our Safety Experts

Learn more about three key solutions: Pregnancy Studies, REMS, Safety Registries

White Paper

Scientific Approach to Patient Safety

Optimizing post-marketing safety obligations requires a unified, holistic approach to understand the research need and identify the right design to generate the right data for the right stakeholders in the most efficient manner possible.

Evidera’s consultative approach, combined with our comprehensive expertise across the product lifecycle, allow us to collaborate with clients to identify the best strategic approach for your product’s safety needs. Our peri- and post-approval safety team can help you better understand and manage your product’s risk-benefit profile and create an evidence generation strategy to not only meet regulatory expectations but identify other opportunities to maximize your asset’s benefits relative to risk across your safety studies.

Additional Perspectives From Our Experts

Registries in Rare Disease Research: Approaches to Optimize Success

Registries provide crucial data to better understand a disease and plan more effective real-world studies. Our white paper discusses how advancements in rare disease treatments have influenced the protocol for registries.

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The Importance of Flexible Pregnancy Safety Study Solutions: An Example in COVID-19 Vaccines

Gain insight into the crucial need for observational pregnancy safety studies as a complement to pre-approval clinical in our webinar.

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The Critical Need for Pregnancy Registry Studies and Robust Safety Monitoring in COVID-19 Vaccines

Clinical trial data are currently limited around the safety of COVID-19 vaccines in pregnant women. In this blog post, Deborah Covington, Senior Research Leader, Real-World Evidence, explores the need for pregnancy registry studies to aid in active data collection.

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REMS: To Outsource or Not to Outsource?

Implementing and managing a REMS program requires specific skills and expertise. In this blog, Debbie Cheslow, Director, Risk Management Programs, discusses the pros and cons of outsourcing a REMS program versus developing one internally.

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Post-Marketing Safety Studies

Patient safety is always the first priority. A well-planned post-marketing safety strategy can make all the difference.

Learn more about three key solutions: Pregnancy Studies, REMS, Safety Registries

The Need for Flexible Pregnancy Safety Studies

Four Common Missed Opportunities When Designing and Developing a REMS Program

Post-Marketing Safety Registries: What, When, Why, How?

Scientific Approach to Patient Safety

Additional Perspectives From Our Experts

Registries in Rare Disease Research: Approaches to Optimize Success

The Importance of Flexible Pregnancy Safety Study Solutions: An Example in COVID-19 Vaccines

The Critical Need for Pregnancy Registry Studies and Robust Safety Monitoring in COVID-19 Vaccines

REMS: To Outsource or Not to Outsource?

Would you like more information about our post-marketing safety solutions or to speak to one of our safety experts?

Patient safety is always the first priority.
A well-planned post-marketing safety strategy can make all the difference.