A collaboration between Cytel and Pulse Infoframe will support rare disease drug development sponsors seeking real-world evidence where the data generated can be used for a range of purposes, from synthetic controls and comparative effectiveness to pricing reimbursement. Cytel, a leader in the field of advanced analytics for life sciences, has spent the past 30 pioneering new methods to ensure data reveals its full value. It has seen regulatory success in obtaining drug approval by leveraging real-world data as a synthetic control arm in clinical trials. 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.
Dr. Radek Wasiak, Chief Data Officer and the Head of Real World and Advanced Analytics at Cytel, said: “Advances in precision medicine enable life sciences companies to develop better and more targeted treatments. However, in rare diseases, this translates to practical difficulties in executing the necessary research activities. Combining Cytel’s pioneering advances in efficient clinical trial design with Pulse Infoframe’s healthie platform and therapeutic area expertise will accelerate our ability to provide our life sciences partners with research needed to obtain regulatory and payer approval.”
Dr. Femida Gwadry-Sridhar, the CEO and founder of Pulse Infoframe, commented: “Rare disease patients can wait years for even the smallest advancement in treatment. In many cases, those advancements may not come at all. By collaborating with Cytel, a company renowned for their quantitative methods for improved research outcomes and exemplary trial design, we can help accelerate drug development for rare diseases.”