Clinical studies of drugs to treat orphan diseases are often limited by the low prevalence of these diseases and as a result complete data from clinical trials may not be available. Moreover, commonly used strategies to collate data for evaluation of post marketing safety and efficacy may not be applicable in cases of orphan drugs. Alternative approaches such as well-designed patient registries are required for collection of real-world data for orphan drugs/diseases.
At orphan reach, we recognize and understand the unique requirements and nuances associated with post marketing surveillance of orphan drugs. We offer specialized services for patient registries. orphan reach team has extensive experience in designing, implementing and managing orphan drug registries. We provide our clients with comprehensive data sets from these registries and help them in meeting their post authorization commitments.