Accelerating Cardiovascular Trials in Outpatient Settings Nationwide
ORCA brings clinical trials directly to your site and manages the entire data lifecycle — from startup to closeout — so you can focus on what matters most: patient care.
Transforming every patient encounter into scientific discovery.
Trusted by outpatient facilities across the United States
15
Sites Under Contract or Review
25+
Doctors at 12 Sites Enrolling
125+
Patients Enrolled in Research
30 Days
Average Site Activation Time
Top
Enrollers in National Cardiovascular Trials
Industry average site activation: 90+ days. ORCA activates in 30 days or less.
Our North Star
Where Clinical Research Meets Artificial Intelligence
ORCA's ambition extends far beyond traditional site management. We are building the intelligence layer that connects cardiovascular research, clinical care, data, and AI — transforming every clinical encounter into an opportunity to advance science.
Accelerating the Advancement of Cardiovascular Medicine
We seamlessly integrate clinical research into everyday patient care, leveraging technology, data science, and artificial intelligence to deliver faster insights, better therapies, and improved outcomes for patients worldwide.
"Advancing cardiovascular science through research, data, and AI."
The Operating System for Cardiovascular Research
We are building the world's leading AI-enabled cardiovascular research ecosystem — a Data Integrated Clinical Environment that uses ambient AI, real-time clinical data, and intelligent workflows to connect physicians, patients, health systems, sponsors, and innovators through a unified platform.
"A future where every cardiovascular patient encounter contributes to scientific discovery and every physician participates effortlessly in research."
ORCA 2035
ORCA began as a clinical research organization focused on bringing innovative cardiovascular studies to outpatient practices. Our future is far more ambitious.
We envision a connected research ecosystem where ambient AI captures clinical information in real time, identifies eligible patients automatically, streamlines study execution, and generates actionable insights across an entire network of physicians, health systems, sponsors, and innovators.
By combining research operations, clinical workflows, and longitudinal patient data into a single intelligent platform, ORCA will enable faster evidence generation, accelerate regulatory pathways, improve patient access to innovation, and create one of the most valuable cardiovascular data assets in healthcare.
Core Competencies
Comprehensive Research Capabilities
From study startup to closeout, ORCA manages every aspect of the clinical data lifecycle with precision and regulatory expertise.
Study Startup & Site Activation
Targeted site selection powered by advanced EHR queries that match protocol criteria to real patient populations — ensuring the right sites are chosen before a trial begins.
Regulatory Submissions & Compliance
Full support for IRB submissions, FDA documentation, and ongoing regulatory maintenance throughout the trial lifecycle.
Patient Recruitment & Engagement
Targeted patient identification using advanced EHR queries — matching protocol-specific inclusion/exclusion criteria to real patient populations across our site network before enrollment begins.
Data Management & Quality Assurance
Rigorous data collection, source document verification, and quality control protocols that ensure audit-ready records.
Site Monitoring & Oversight
Proactive monitoring, issue resolution, and site performance optimization to maintain trial momentum.
Study Closeout & Reporting
Thorough closeout procedures, final data reconciliation, and comprehensive reporting for sponsors and regulatory bodies.
How We Work
End-to-End Support, Seamlessly Integrated
Our centralized SMO model brings clinical research expertise directly to outpatient facilities. We handle every phase — from feasibility and startup through closeout — while integrating smoothly into your existing clinical workflows.
Targeted Site Selection via EHR Query
We query real-time EHR data across our network to identify which sites have the highest concentration of eligible patients — selecting sites based on actual patient populations, not guesswork.
Startup & Activation
Regulatory submissions, contracts, and site training — managed end-to-end.
Study Conduct & Monitoring
On-site and remote CRC support with proactive monitoring throughout the trial.
Closeout & Reporting
Complete data reconciliation, regulatory closeout, and final deliverable handoff.
100%
Trial lifecycle coverage
50+
Active endovascular trials supported
Our Specialty
Leading the Industry in Endovascular Research
ORCA is at the forefront of accelerating outpatient endovascular research. Our deep expertise in managing Investigational Device Exemption (IDE) studies and post-market surveillance studies positions us as a trusted partner for the most innovative peripheral vascular, venous, and interventional therapies in development today.
Clinical Sites
Bring clinical trials to your outpatient facility with minimal disruption to your existing workflows. ORCA provides the infrastructure, staff, and regulatory support you need to participate in cutting-edge cardiovascular research.
- Minimal disruption to clinical workflows
- Access to cutting-edge cardiovascular trials
- Full regulatory and compliance support
- Additional revenue stream for your practice
Sponsors & CROs
Accelerate your cardiovascular clinical trials with ORCA's nationwide network of outpatient sites, experienced CRCs, and proven regulatory expertise. We deliver high-quality data, faster enrollment, and audit-ready documentation.
- Nationwide network of qualified outpatient sites
- Experienced cardiovascular CRC workforce
- Accelerated patient enrollment timelines
- FDA-compliant, audit-ready data management
Data as Strategic Asset
ORCA as a Data Purveyor
Beyond site management, ORCA transforms clinical research data into a strategic asset. Our advanced EHR query capabilities allow us to predictively match protocol criteria to actual patient populations — enabling targeted site selection, accelerated enrollment, and richer datasets that power innovation across the cardiovascular industry.
Data Collection
Advanced EHR queries that predictively match protocol criteria to patient populations — enabling targeted site selection across all ORCA sites
Data Management
Centralized, audit-ready EDC systems with source document verification and quality assurance
Data Analytics
Advanced analytics, predictive modeling, and real-time performance dashboards for sponsors
Data Insights
De-identified datasets and aggregated analytics supporting industry research and innovation
Trusted Partners
Companies ORCA Has Delivered For
ORCA has served as a trusted research partner for leading endovascular and peripheral vascular device companies.
AcoTec Technologies Limited
Amplitude Vascular Systems, Inc
Angiodynamics, Inc
Aveera Medical Inc.
Concept Medical, Inc.
NAMSA / Re-Sorb
Philips Image Guided Therapy Corp
Protexa Endovascular, LLC
R3 Vascular
Summa Therapeutics, LLC
Venova Medical, Inc
Versono Medical Limited
Start the Conversation
Let's Advance Cardiovascular Research Together
Whether you're a clinical site looking to bring trials to your practice, a sponsor seeking a reliable research partner, or a talented CRC interested in joining our team — we want to hear from you.
Clinical Sites
Bring cutting-edge cardiovascular trials to your outpatient facility with full ORCA support.
Sponsors & CROs
Partner with a nationwide network of outpatient sites and experienced cardiovascular CRCs.
Careers
Join our growing team of Clinical Research Coordinators and research professionals across the U.S.