London, Canada; Rhode Island, United States (June 24, 2021) – QualityMetric and Pulse Infoframe announced today their partnership and vision to create the first scientifically validated rare disease instruments across conditions. Once deployed, these instruments will benefit not only rare disease patients and families, but also researchers and drug developers working to help this vastly underserviced population as they advance rare disease care and treatments.
In rare disease, the clinical endpoints used to evaluate the efficacy of new treatments in clinical trials are not always well understood. In pursuit of drug approval from the FDA, EMA and other regulatory agencies, standardized or custom disease-specific patient-reported outcome (PRO) tools are important to establish the clinical meaningfulness of these endpoints.
Combining QualityMetric’s clinical outcomes assessment (COA) scientific expertise, PRO data science, and technology with Pulse Infoframe’s data science expertise and comprehensive real-world data platform for evidence generation and regulatory decision-making solution for patients, clinicians, and researchers, this partnership has the potential to transform the rare disease space.
“The ability to measure and benchmark quality of life, physical health, mental health, and disease-specific domains in a scientifically validated way gives the patient a stronger voice and provides the community with access to a dataset that does not exist today,” says Pulse Infoframe founder and Chief Executive Officer Dr. Femida Gwadry-Sridhar. “That’s why we’re excited to work with QualityMetric.”
“We’re very excited to combine our solutions and expertise with Pulse Infoframe’s innovative rare disease platform, Rare Central™,” says Gus Gardner, Chief Executive Officer of QualityMetric. “We have helped numerous clients utilize clinical outcomes assessments to illuminate how diseases impact patients with rare conditions. Pulse Infoframe’s rare disease platform goes beyond data collection to offer researchers, sponsors and other professionals an end-to-end solution for evidence strategies.”
The partnership between QualityMetric and Pulse Infoframe will benefit the rare disease ecosystem including patients, advocacy, researchers and pharma/biotech through:
- Improved understanding of a disease, disease trajectory and progression
- Decreased time to diagnosis
- Development of disease-specific surveys and instruments, including severity scales for staging and outcome measures
- Available scientific expertise to develop (design, delivery and interpretation) psychometric validation of patient-reported outcomes measures
- Access to natural history studies for use as a comparator arm/synthetic cohort
- Experienced in navigating the processes necessary to meet FDA and EMA requirements
- Expedited approval process and speed-to-market due to availability of standardized evidence
QualityMetric instruments will be available as part of the healthie™ library within Pulse Infoframe’s Rare Central™ offering, simplifying configuration and start-up time. This globally deployed rare disease patient registry platform can integrate with a wide variety of healthcare data sources including EHR, claims, genomics and existing registries. Its technology allows a defined data dictionary and applies the latest global data mapping standards, including Observational Medical Outcomes Partnership (OMOP) and Clinical Data Interchange Standards Consortium (CDISC), to facilitate FDA- and EMA-ready research.
QualityMetric is a leading global COA solutions provider and technology-enabled scientific consultancy specializing in patient-reported outcome measures. Our solutions capture, analyze and interpret patient experiences through reliable measurement tools and multidisciplinary research expertise. With a comprehensive suite of scientifically validated PRO surveys, integrated COA technology and strategic consulting services, QualityMetric helps researchers obtain the evidence to make decisions through the use of valid and reliable assessments of functional health and well-being. QualityMetric is owned by Vesey Street Capital Partners, LLC (VSCP), a New York-based healthcare services private equity firm. Learn more at www.qualitymetric.com.
About Pulse Infoframe
Pulse Infoframe is a real-world evidence generation, health informatics and insights company that provides a technology and services platform designed to extract, curate, analyze and disseminate evidence-based conclusions that improve the quality of people’s lives. Pulse Infoframe provides a full solution for registries, natural history studies and a range of other observational and regulatory grade studies. With provider relationships for patient access, Pulse Infoframe ensures that insights, evidence and publication results are disseminated across the ecosystem, including advocacy organizations, key opinion leaders, researchers and sponsors. Learn more at www.pulseinfoframe.com.