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The use of observational research is increasing, as regulators, payers, and patients require more long-term data on product safety and effectiveness, as well as demanding the product’s demonstrated value in treating disease. This paper helps you to understand and apply the fundamental principles of observational research, and to take advantage of the value and potential of this approach.
This white paper gives an overview of the role of observational research in the pharmaceutical industry by exploring 5 basics:
1. The rationale for the conduct of observational research
2. A high level overview of the application of observational research in clinical development and life cycle management
3. Definitions of key observational research terms
4. Descriptions of the main types of observational research studies
5. A discussion of the governance of observational research studies and a review of the regulatory
landscape in the EU and US with respect to regulation, legislation, and guidance documents that influence the role of observational research
A phase-dependent approach has potential to cut costs by avoiding investing in riskier assets, utilizing secondary…
However promising a product might appear, if you do not have the right evidence early on (or if you fail to recognize…
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