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Post-Approval

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.