Cytel and Pulse Infoframe Deploy Real-World Data Solutions

Cytel and Pulse Infoframe have collaborated to create a solution that marks a new direction in drug research and development for rare diseases.

Dr Femida Gwadry-Sridhar, CEO and Founder of Pulse Infoframe and Dr Radek Wasiak, Director of Data and Head of Real and Advanced World Analysis at Cytel

Collaboration between Cytel and Pulse Infoframe creates a solution that marks a new direction in rare disease research. This partnership will support drug development sponsors seeking to implement real-world evidence solutions where the generated data can be used for a variety of purposes, from synthetic controls and comparative efficacy to reimbursement of prices.

Cytel, a leader in advanced analytics for life science decision makers, has spent the past three decades pioneering new ways to ensure data delivers its true value. It is one of the few companies that has successfully gained regulatory approval for a drug by harnessing 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 data captured is mapped according to global standards such as the Observational Medical Outcomes Partnership (OMOP ) and the Clinical Data Interchange Standards Consortium (CDISC).

The two companies will combine their expertise to channel real-world evidence into breakthrough new treatments for rare diseases. Because rare disease research and drug development have historically faced limited sample sizes, they have required innovative approaches for clinical development and generation of evidence. Using real-world data to underpin regulatory and payer submissions is therefore essential to ensure that stakeholders examine the most comprehensive set of evidence, allowing faster access to new treatments in areas where the need is greatest. high but not satisfied.

Dr Radek Wasiak, Chief Data Officer and Head of Real World Analysis and Advanced Analytics at Cytel, says, “Advances in precision medicine allow life science companies to develop better and more targeted treatments. However, in rare diseases this results in practical difficulties in carrying out the necessary research activities. Combining Cytel’s pioneering advancements in ineffective clinical trial design with Pulse Infoframe’s healthie ™ platform and therapeutic domain expertise will accelerate our ability to provide our life science partners with the research needed to obtain approval from regulatory authorities and payers.

Dr Femida Gwadry-Sridhar, CEO and Founder of Pulse Infoframe, says, “Patients with rare diseases can wait years for even the slightest progress in treatment. In many cases, this progress may not happen at all. By working with Cytel, a company known for its quantitative methods of improving research results and the design of exemplary trials, we can help accelerate drug development for rare diseases.

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