Registries & Observational Studies

We are a leader in the design and implementation of registries and observational studies to address the needs of patients, health care providers, regulatory authorities, and manufacturers.

Our epidemiologic approach to registries focuses on collecting relevant data to understand and guide real-world use of biopharmaceuticals and devices, throughout the product lifecycle.

We are specialists in the design and implementation of observational studies, including streamlined programs that aid the understanding of real-world product use, medical practices, and treatment patterns.

Product & Disease Registries

We design and implement registries to study and guide the use of biopharmaceuticals and devices and to understand the treatment of diseases and health conditions.

Our registries can address a broad range of issues:

  • Safety – confirm appropriate product use and estimate incidence of adverse events; provide information to guide and control product use to help minimize risk
  • Regulatory – address post-marketing commitments; evaluate risk management programs
  • Research – collect data on real world use for publication & presentation; develop hypotheses for future study; collect resource utilization data for economic evaluations; collect data on off-label use; establish a "stored cohort" for future use
  • Education – provide data on real world product use and disease treatment to health care professionals and payers
  • Practice Modification & Improvement – document practice patterns and outcomes associated with use of new and mature products; compare actual practices to national/global norms or guidelines
  • Commercial – understand behavior of early and late adopters; understand product switching; build market intelligence on competitive products
Pregnancy Exposure Registries

We design and implement registries to obtain health information from women who take biopharmaceuticals when they are pregnant and newborns who may have been exposed to these products.

We focus on two types of pregnancy registries:

  • Stand-alone programs
  • Registries associated with one or more clinical trials.
Prospective Observational Studies

The collection of real-world health care data is essential to evaluate the potential impact of therapies or devices in actual practice. We design and conduct custom-tailored data collection studies, using innovative electronic data capture methodologies and infrastructures to ensure that quality data are available for analysis in real-time.

We have designed, conducted and published multi-national studies and surveys to collect epidemiological, burden of illness, and health and social service resource use endpoints for use in economic models or other research studies. Our multi-disciplinary team approach combines scientific experience and expertise across health economics, outcomes research and registries.

Our data collection research study methodologies include:

  • Surveys
  • Observational prospective and cross-sectional studies
  • Time and motion studies
  • Disease-specific and multi-national resource utilization questionnaires
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