At INC Research, we understand the design and implementation nuances that differentiate post-approval research from pre-approval development – nuances that are critical to consider if you are to achieve success with your post-approval research initiatives.
|INC Research Post-Approval is focused on the efficient and cost-effective delivery of studies and support programs designed to meet your global needs for real-world data. We offer specialized support for:
- Patient registries (disease/event and product)
- Safety surveillance studies
- Large simple studies
- Prospective observational studies
- Health outcomes research
- Quality of life
- Patient-Reported Outcomes (PRO)
- Phase IV effectiveness trials (non-IND)
- Health economics studies
- Retrospective chart reviews
- Expanded access program
- Extending the lifecycle
We have a dedicated clinical operations team with tools and study implementation procedures specifically created for late phase research. Our in-house site management teams – CRAs and other site support specialists – use customized telephone and web technologies to remotely manage study sites, support patient enrollment and help ensure overall data quality. Our proprietary post-approval study management system ensures real-time support for sites and comprehensive up-to-date status reports for our customers.
For more information on INC Research’s Post Approval capabilities, click here.