Medical Registries and Post Market Surveillance Studies

Tii has extensive experience in the design, management and operation of medical registries and post market surveillance studies in both the United States and abroad.

These studies enable our clients to successfully address late stage and post-approval regulatory requirements and generate product experience data from a real-world setting. Medical registries and post market surveillance studies are typically large, multi-year, observational studies that provide critical data for:

  • Gaining competitive market intelligence
  • Establishing a leadership position within therapeutic areas of interest
  • Obtaining product safety and effectiveness information
  • Generating hypotheses to guide additional research
  • Accelerating the commercial acceptance of new products
  • Cultivating positive relationships with clinicians and patients
  • Complying with FDA orders

Tii's expertise includes, but is not limited to:

Services offered by Tii

Our staff has extensive experience in working with numerous types of medical registries including:

  • Surgical registries - Surgical registries focus on the management and outcomes of specific high risk surgical procedures, providing insight into the risk of such procedures and the progression of new techniques and therapies used for treatment.
  • Disease registries - Disease registries focus on the management of a specific disease or condition, providing insight into disease progression and therapies used for treatment.
  • Product registries - Product registries focus on use of a specific therapy or device and provide data on its treatment effectiveness and patient compliance. We have broad therapeutic experience and our staff includes researchers with extensive background in clinical development.
  • Safety registries - Safety registries are designed to capture and document ongoing safety, effectiveness and outcomes data from real-world patient populations under actual treatment conditions. Typically required by the FDA, especially if clinical trial data is from a small patient population, Tii can apply our expertise in risk management programs and design safety registries, an integral part of an overall risk management strategy.