Meeting your products’ safety information needs
i3 Drug Safety epidemiology experts serve as key advisors to sponsors, regulators, and payers on how to best meet a product’s safety information needs, and they stand ready to provide you with the best in reliability, clarity, data quality, and technical expertise.
Beyond information to real insight
Your teams will benefit from our research leaders’ access to our proprietary research database of de-identified health care and administrative data that links patient, physician, and treatment attributes on more than 25 million geographically diverse individuals in the US.
Working together, we will help you develop proactive information plans, and then leverage our rich data assets to create large patient follow-up programs that meet post-marketing regulatory requirements for safety surveillance, analysis, and reporting.
Our services include:
- Custom designed prospective and retrospective studies
- Patient registries
- Natural history of disease
- Clinical epidemiology
- Pharmacogenetics
- Birth registries
- Comprehensive Risk Management Plans for marketed products
In addition, we can help you monitor the safety of your newly launched drugs quickly and effectively with i3 Aperio®, our unique signal detection and assessment tool.
Our experts stand at the forefront of epidemiologic design and practice—where your program can be.
A reputation for scientific rigor and integrity
Call on our epidemiology experts—they are recognized for their scientific rigor and integrity. Having appeared before the FDA, EMEA, and scores of professional congresses, as well as contributing to leading publications on drug safety that include a wide range of drug safety studies and advances in epidemiologic methods research, our experts stand at the forefront of epidemiologic design and practice. |