Cytel, a leader in the field of advanced analytics for life sciences decision makers, has spent the last thirty years pioneering new methods to ensure data reveals its full value. It is one of the few companies that has had regulatory success obtaining drug approval by leveraging real-world data as a synthetic control arm in a clinical trial. The new collaboration builds on Cytel’s expertise in clinical trial design and real-world data solutions.
Pulse Infoframe’s healthie™ platform simplifies the workflow for data capture, integration, and management, while ensuring that all the data captured is mapped according to global standards such as Observational Medical Outcomes Partnership (OMOP) and the Clinical Data Interchange Standards Consortium (CDISC).
Both companies will combine their expertise to channel real-world evidence toward ground-breaking new treatments in rare disease. Because rare disease research and drug development have historically been confronted with limited sample sizes, they have required innovative approaches to clinical development and evidence generation. The use of real-world data to support regulatory and payer submissions is therefore essential to ensure that stakeholders review the most comprehensive evidence package, enabling faster access to new treatments in areas of high yet unmet need.