With a commitment to advancing innovation in patient registries from inception through implementation, the Registries CoE represents a pivotal step toward addressing critical gaps in clinical research
Business Wire

BOSTON–(BUSINESS WIRE)–OM1, the leader in delivering first-in-class RWE technological advancements and AI-powered insights; today, launches its Registries Center of Excellence (CoE). Dr. Richard Gliklich, CEO and founder of OM1, and Michelle Leavy, Senior Director of Registries, have established a center featuring a cohort of experts offering unparalleled expertise and consultation.

Dr. Gliklich, a champion of patient registries and senior editor of the widely acclaimed Agency for Healthcare Research and Quality publication, “Registries for Evaluating Patient Outcomes: A User’s Guide: 4th Edition,” said: “Scientific, technical, and operational components of prospective studies and registries are highly interdependent, with substantial room to introduce advanced solutions to streamline and improve research. We’re at an exciting and fundamental moment in medical research, and the CoE will provide us with another way to serve as a strategic, end-to-end partner to our customers as they embark on a journey to reduce the financial burdens of research and speed products to patients for life-changing treatments.”

As regulatory guidance around the utilization of RWE for submissions is evolving, the FDA released its finalized guidance on December 22, 2023, for the industry titled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.” The guidance covers several crucial aspects, including fitness-for-use, data linking, FDA review of submissions, considerations on selection, description, verification, and validation of registries for use in clinical investigations, and the use of registry data for trial endpoints, risk identification, data retention, and protection.

Understanding the need for comprehensive solutions in clinical research, OM1 built the Registries CoE in tandem with OM1 Aspen—the company’s novel and world’s first automated study platform for evidence generation that enables AI-powered data automation in the collection, processing, linkage, and data enrichment of studies leveraging RWD sources at scale. OM1’s Registries CoE will offer unparalleled subject matter expertise and consultation throughout the project lifecycle and guide innovation in patient registries from concept through design, operations, and analysis. By providing expert consultation with its industry-first platform, OM1 aims to help clients and partner organizations rapidly benefit from this emerging paradigm for more automated and registry-based clinical research, including embedded trials and comparator arms.

The Centers of Excellence will provide several key consultation functions to benchmark practices:

  • Data Collection and Management: Generate new evidence and registries to meet safety, effectiveness, quality, or value goals leveraging EHRs, existing registries, claims, social determinants, and other data sources, combined with outcomes collection from clinicians and patients.
  • Standardization and Quality Assurance: Implement practices and rigorous QC measures to ensure data consistency, accuracy, and reliability.
  • Advanced Analytics/AGI/AI: Utilize advanced analytical methods, including artificial intelligence (AI) and machine learning (ML), to extract meaningful insights from the collected data, provide data enrichment, and enhance value to sites and patients in new and meaningful ways.
  • Regulatory Compliance: Ensure data collection, storage, and analysis processes comply with regulations and guidelines, for ‘fit-for-purpose’ data for regulatory submissions.
  • Outcome Research: Conduct studies to evaluate the effectiveness, safety, and value of medical treatments, interventions, and healthcare practices in real-world settings. This includes registries in clinical trial ECAs, observational studies, safety studies, and supplementary evidence submissions for regulatory bodies.
  • Patient-Centric Approaches: Incorporate virtual sites and patient-reported outcomes, experiences, and preferences into research to ensure findings benefit patients.
  • Collaboration and Partnerships: Partner with HCPs, payers, researchers, and other stakeholders to promote the use of RWE in clinical practice and decision-making.
  • Education and Training: Provide training and educational resources to healthcare professionals and researchers using RWE and RWD.
  • Innovation and Technology Development: Advance the development and implementation of new technologies and methodologies for data collection, analysis, and evidence generation.
  • Policy Advocacy: Engage policymakers to advocate for integrating RWE into healthcare policy and decision-making processes.
  • Reporting and Dissemination: Publish and disseminate research findings through scientific journals, conferences, and other platforms to share insights with the broader medical and scientific communities.

“Rapid advances in registry methodology can introduce efficiencies, but they may also lead to confusion and misalignment across stakeholders with different areas of expertise and expectations for registry data,” said Michelle Leavy, MPH, Senior Director of Registries, OM1. “The Registries CoE will give our customers access to strategic, personalized planning so they can plan and build efficient, feasible, and flexible registries to address evidence needs that evolve over time.” As an epidemiologist and the managing editor of “Registries for Evaluating Patient Outcomes: A User’s Guide,” Leavy will lead the CoE and oversee prospective observational studies and patient registries.

OM1’s innovation aims to advance the next generation of research that will have a far-reaching impact across the industry for RWE regulatory submissions. Our newly created Centers of Excellence and Aspen automated study platform will support companies in delivering regulatory-grade evidence without the inefficiencies common in pragmatic trials.

To learn more about OM1’s real-world data, AI, and integrated evidence platforms, please email info@om1.com.

About OM1
OM1 is pioneering cutting-edge healthcare innovation through its insights-driven technology and data. It specializes in personalized medicine, evidence generation, and real-world evidence (RWE) research powered by next-generation AI platforms, regulatory-grade deep longitudinal data, and globally recognized thought leadership. OM1 is led by a diverse group of scientists, engineers, researchers, and clinicians with over 30 years of experience in RWD/RWE who have written the handbook on building clinical registries and developing the outcomes measure framework. OM1’s unprecedented innovation takes RWE from bench to practice, delivering unparalleled personalized impact on the outcomes of patients and the advancement of research.


Alyssa Horowitz