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
- 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
- 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:
- Observational prospective and cross-sectional
- Time and motion studies
- Disease-specific and multi-national resource