News & Events

NERI’s Registries Respond to Unmet Industry and Patient Needs continued

NERI understands that registries have evolved from basic lists of people with specific medical conditions into more complex databases that carefully monitor disease states and track outcomes of various medical interventions. In general, NERI registries fall into three primary categories:

   1. Disease Registry
         1. Specific condition
         2. Rare diseases
         3. Exacerbation of underlying disease
   2. Product Registry
         1. Pregnancy exposure
         2. FDA regulated (as a condition of commercialization approval, such as post-market surveillance)
         3. CMS mandated (as a condition for reimbursement or certification)
   3. Health Services Registry
         1. Patient report outcomes
         2. Healthcare resource utilization

NERI has significant experience with the planning, implementation and management of multi-site registries. These cutting-edge resources are used for the following reasons:

• Provide a source of potential patients for clinical trials
• Observe natural history and disease progression
• Fulfill post-market (drug, device, biologic) surveillance
• Obtain real-world clinical outcomes
• Assess quality of life and cost effectiveness
• Determine clinical practice patterns
• Evaluate safety and effectiveness

NERI registries include men, women and children and address a variety of therapeutic areas. For example, some ongoing registries include information about endovascular grafts, sleep disorders, hormonal deficiency and sexual dysfunction. One of NERI’s longest running registries has been around for more than 12 years and is focused on pediatric cardiomyopathy.