How the ORCA Model Works
ORCA is a centralized SMO purpose-built for outpatient cardiovascular research. We own every phase of the trial lifecycle — from targeted site selection via advanced EHR query through closeout — embedding seamlessly into your clinical environment so research and patient care coexist without friction.
A Different Kind of SMO
Centralized Operations, Distributed Reach
Traditional SMOs fragment responsibility across sites and sponsors. ORCA consolidates everything — regulatory, financial, staffing, data — under one operational roof while placing experienced CRCs directly inside outpatient facilities. The result is faster activation, cleaner data, and trials that actually enroll.
30-Day Site Activation
ORCA activates sites in 30 days or less — three times faster than the industry average of 90+ days. Pre-negotiated master clinical trial agreements and streamlined IRB pathways eliminate the bottlenecks that slow every other SMO.
Outpatient-Native Model
Unlike hospital-based research programs, ORCA is built from the ground up for outpatient and office-based lab environments — lower overhead, fewer institutional hurdles, and direct physician-patient relationships that accelerate enrollment.
Embedded CRC Workforce
ORCA deploys trained cardiovascular and endovascular Clinical Research Coordinators directly to site — on-site or hybrid — providing the human infrastructure that keeps trials moving without burdening clinical staff.
Regulatory Infrastructure
From IRB submissions and FDA correspondence to protocol amendments and deviation management — ORCA owns the regulatory burden entirely, submitting correctly the first time to prevent costly delays.
Real-Time Data Intelligence
Proprietary EHR query tools and developing AI analytics give ORCA — and its sponsor partners — live visibility into actual patient populations. This enables predicted site selection, real-time enrollment pipeline tracking, and site performance benchmarking across the entire network.
Business Development Engine
ORCA actively builds and manages sponsor relationships on behalf of its site network. Sites receive a continuous pipeline of trial opportunities matched to their patient population and investigator expertise.
The Trial Lifecycle
End-to-End Support, Every Phase
ORCA manages the complete data lifecycle — no handoffs to third parties, no gaps in coverage.
Phase 01
Targeted Site Selection via EHR Query
Phase 02
Startup & Activation
Phase 03
Study Conduct & Monitoring
Phase 04
Closeout & Reporting
The ORCA Model by the Numbers
30Days
Average site activation vs. 90+ day industry norm
125+
Patients enrolled across ORCA's trial portfolio
15Sites
Under contract or in active review
25+Doctors
Across 12 sites actively enrolling in ORCA trials
Who It's For
Built for Both Sides of the Trial
Clinical Sites & Investigators
ORCA handles the administrative and operational complexity of clinical research, creating a turnkey research program within your outpatient practice — no matter your experience level.
Learn more for sitesSponsors & CROs
ORCA provides the infrastructure layer between your device innovation and the patients who need it — delivering enrollment speed, data quality, and outpatient reach that hospital-based programs cannot match.
Learn more for sponsorsSee the ORCA Model in Action
Whether you're a site looking to launch your first trial or a sponsor seeking faster enrollment, ORCA has the infrastructure to deliver.