Comparison X-rays of right superficial femoral artery before and after percutaneous transluminal angioplasty procedure
For Sponsors & CROs

The Infrastructure Layer for Outpatient Clinical Research

ORCA bridges device innovators and clinical sites through real-time EHR data science — delivering faster enrollment, higher data quality, and unmatched outpatient reach. Our developing AI platform will further accelerate these capabilities as we build toward the future of cardiovascular research.

The ORCA Difference

Bridging Innovation & Clinical Reality

ORCA is not a traditional CRO or SMO. We are the data-powered infrastructure layer between device innovators and outpatient clinical sites — connecting the right patients to the right trials through real-time EHR intelligence and a pre-qualified site network. Our developing AI platform represents our north star for the future of cardiovascular research.

Real-Time EHR Data Assessment

ORCA's proprietary EHR data tools query patient populations across our site network in real time — identifying eligible candidates before a trial even activates. We use advanced EHR queries to target the right sites based on actual patient counts, not retrospective chart pulls.

Future AI-Driven Enrollment Engine

Our AI platform under development will continuously refine targeted site selection, patient identification, and enrollment forecasting using advanced EHR queries. Our north star: predict which sites will perform before a trial activates, based on real patient populations, not guesswork.

Rapid Site Activation

ORCA activates sites in 30 days — 3× the industry standard. Pre-negotiated MCTAs, streamlined IRB pathways, and trained CRCs on the ground mean your trial reaches first patient faster, every time.

Nationwide Outpatient Network

Access a curated network of outpatient cardiovascular and endovascular practices — interventional cardiologists, vascular surgeons, and interventional radiologists — with demonstrated enrollment track records.

Data Science & Quality Assurance

ORCA's data management infrastructure delivers audit-ready EDC systems, source document verification, and real-time site performance dashboards. Sponsors get clean, defensible data on accelerated timelines.

Proven Enrollment Performance

ORCA sites have been the top enrollers in several national endovascular trials. Our network has enrolled 125+ patients across IDE studies, post-market surveillance studies, and device feasibility studies with leading sponsors.

Syringe with medication and magnified closeup showing blue liquid being administered through needle

125+ Patients

Enrolled across ORCA's endovascular trial portfolio

Proprietary Technology

Real-Time EHR Intelligence & Future AI

Traditional feasibility relies on retrospective chart pulls and physician memory — an educated guess at best. ORCA's advanced EHR query tools give sponsors an accurate, live count of eligible patient populations at each site before site selection. We predict performance based on actual data, not estimates, enabling targeted site selection that compresses timelines and eliminates guesswork.

Targeted Site Selection via EHR Query

Advanced EHR queries match protocol inclusion/exclusion criteria against real patient populations — identifying which sites have the highest concentration of eligible patients before a trial even activates.

Predictive Site Selection

Our data models rank sites by actual patient counts, historical enrollment performance, and protocol fit — enabling predicted site selection that puts the highest-performing sites in front of sponsors first.

Future AI Assisted Enrollment Forecasting

Platform being developed: Machine learning models trained on ORCA's enrollment data will generate accurate enrollment projections and alert to screen failure risks before they occur.

Ongoing Performance Analytics

Sponsors get real-time dashboards showing site-level enrollment rates, data quality metrics, and protocol deviation trends — full transparency throughout the trial.

Full Sponsor Support

What ORCA Delivers for You

Speed & Enrollment

Site activation in 30 days or less
Advanced EHR query for targeted site selection — know your patients before you activate
Future AI-assisted enrollment forecasting (platform in development)
Top enrollment performance in national endovascular trials
Pre-screened, protocol-ready patient populations identified via EHR query
Predicted site performance based on actual patient counts, not estimates

Quality & Compliance

FDA-compliant, audit-ready data management
Dedicated CRC oversight at every site
Real-time data quality monitoring dashboards
Proactive protocol deviation prevention
Source document verification and QA
ICH GCP-compliant trial execution across all sites

Trial Types We Specialize In

ORCA's network and expertise is purpose-built for the endovascular and peripheral vascular therapeutic landscape.

Drug-Eluting Peripheral Balloon Trials
Endovascular Stent & Stent Graft Studies
Critical Limb Ischemia (CLI) Trials
IDE Device Feasibility Studies
Post-Market Surveillance Studies (PMCF)
Peripheral Arterial Disease (PAD) Trials
Venous Intervention Studies
Limb Salvage Device Trials
Biologic & Drug Infusion Studies
Real-World Evidence (RWE) Studies
Investigator-Initiated Trials (IITs)
Registry & Outcomes Research

Proven Track Record

Companies That Have Trusted ORCA

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

Ready to Accelerate Enrollment?

Partner with ORCA to access the infrastructure, data intelligence, and outpatient site network your trial needs to succeed.