Late Stage Research

Pregnancy Registries: Increasing Safety and Access

Understanding the effects of medications in pregnant women is a public health need that continues to require the highest level of services our industry can provide.

Women of childbearing age have a wide range of medical conditions that require chronic therapy such as diabetes, depression, epilepsy, and asthma. If they become pregnant, they must also face questions regarding the potential impact of their medication on the risk of birth defects.

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Partner with Innovation at PCT EU

As technology takes an even greater hold of healthcare, big data and its uses within all facets of improving patient care is instigating an evolution. Manufacturers are feeling more pressure to realize continued success, while streamlining processes and cutting costs. As these pressures build, traditional methods in clinical development are no longer providing desired results. To achieve more impact, the industry is being asked to take a fresh look at standard processes and the available data.

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Technology in Registries and Observational Studies - What You Should be Considering (Part II)

The increased use and importance of observational studies necessitates sponsor evaluation of standard operating procedures for clinical trials. Often the focus of that evaluation is on methodology, structure, and resulting evidence, but it is just as critical that the technology details be evaluated as well. In the second part of our series, we examine additional facets that should be considered during development of platforms for registries and observational programs.

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Hybrid Study Designs for Demonstrating Real-World Product Safety, Effectiveness and Value

Hybrid study designs which aim to result in high quality data, collected in a rapid and time-efficient manner may be an option when more traditional approaches are not suitable. We have developed a strategic and step-wise approach for the development of optimal study designs to address research questions which warrant multiple data sources including primary or secondary sources of real-world data.

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