Clinical Registries and Automated Studies
OM1 brings experience with 300+ registries and observational studies coupled with agentic data collection and processing, reducing burden and costs, while generating regulatory-ready evidence that’s fit for purpose, scalable, and cost-effective.
Built for Quality and Regulatory-Ready Programs
Trusted by regulators, OM1 supports prospective and retrospective studies that are timely, compliant and cost-effective, and have a history of successful submissions.
Product & Disease Registries
Subscribe to or build disease or product registries with state-of-the-art technology and operational excellence to serve natural history, effectiveness, safety and/or quality purposes.
Post-Approval Safety & Effectiveness Studies
Conduct post-approval safety and effectiveness studies (PASS/PAES) leveraging automation that meet regulatory expectations for design, completeness, transparency, and traceability.
Long-Term Follow-Up (LTFU) & Rollover Studies
Track patient outcomes years after treatment—using automated and patient-mediated data collection and linkage to maximize follow-up and lower costs.
Rare Disease Programs
Accelerate rare disease research by combining targeted patient finding and advanced technology, including patient-mediated data capture, that make low-incidence populations accessible and produce high quality data.
Proven Scale and Performance
patients in the largest real-world regulatory submission to date
patients enrolled in a national LTFU in 18 months
registries and observational studies designed by OM1 experts*
*Senior editors and authors of the leading worldwide reference for registries.
A Smarter Way to Run Real-World Studies
OM1 supports diverse study designs and diseases—from Phase 3b to long-term follow-up programs and from rare to common conditions—while reducing burden and cost.
Engage the Right Patients and Sites: Leverage AI for patient identification, tapping into extensive real-world networks to reach hard-to-find populations. Activate patient-mediated tools for rare populations and to enhance long-term follow-up.
Automate and Enrich with AI: Streamline data acquisition and enrichment with automated processing and linkage across diverse data sources.
Deliver Insights with Confidence: Registry Center of Excellence and expert teams support end-to-end study design through execution and regulatory submission.
Why Leading Organizations Choose OM1 for Clinical Registries and Automated Studies
Lower Costs, Reduced Burden and Higher Site Satisfaction: Broader reach and more complete follow-up. Decentralized approaches broaden recruitment while direct-to-patient data capture significantly improves long-term follow-up at lower costs.
Regulatory Confidence and Experience: Generate high-quality, traceable and auditable data using systems and procedures that have met regulatory expectations.
AI-Powered Insights: Extract important variables from unstructured data with validation.
Flexible for Future Growth: Expand cohorts, add endpoints, or launch nested studies —creating a sustainable foundation to support evolving sponsor and stakeholder needs.
Work with the Experts Who Set the Standard for Registries
Our experts have served as principal investigators, editors, and authors of Registries for Evaluating Patient Outcomes: A User’s Guide (AHRQ), a cornerstone reference for FDA and global regulators.
Evidence in Action
Life Sciences Case Studies from OM1
Case Study
Large-scale comparative study for cancer screening for label expansion
>600k patients submitted for new label indication
Case Study
AI Automation enables largest registry at remarkably lower costs
>1M patients enrolled and followed over 5 years using an agentic-first approach
Case Study
Powering long-term evidence generation in rare dermatologic disease
A 3 year prospective study with 30+ Centers of Excellence
Trusted by Healthcare Innovators
“OM1’s robust, longitudinal real-world data and analytic expertise allowed us to rigorously demonstrate clinical and economic value, producing credible evidence that payers can rely on to inform coverage decisions.”
—VP, Clinical Affairs
“OM1 has been great to work with, not only because of their expertise but because of their ability to shift direction when required and provide guidance. It’s great to know the expertise and collaboration are there.”
—Director of Outcomes
“OM1 is shaping the future of RWE with innovative AI solutions for immunology and oncology.”
—Frost & Sullivan, 2025 Technology Innovation Leadership Recognition
Let’s Talk About Your Goals
From research and evidence to predictive insights and beyond.