Every Service Your Trial Needs
From the first EHR query for targeted site selection to final data lock, ORCA delivers the full stack of clinical research services — purpose-built for outpatient endovascular and cardiovascular trials.
Core Services
Comprehensive Research Capabilities
ORCA manages every dimension of the outpatient clinical data lifecycle with precision, regulatory rigor, and endovascular expertise.
Study Startup & Site Activation
ORCA's fast-track activation platform gets sites research-ready in 30 days. We use advanced EHR queries to target sites with the highest concentration of eligible patients, then handle protocol review, budget negotiation, and pre-activation training before your first patient is screened.
- Targeted site selection via advanced EHR query
- Master Clinical Trial Agreement execution
- Site qualification & initiation visits
- Pre-study protocol training
Regulatory Submissions & Compliance
Full-service regulatory management across the entire trial. ORCA's regulatory team submits correctly the first time — preventing resubmission delays that can add weeks or months to your timeline.
- IRB initial and continuing submissions
- FDA correspondence and IDE support
- Protocol amendment management
- Informed consent development
Patient Recruitment & Engagement
ORCA combines advanced EHR queries targeting protocol-eligible patient populations with on-the-ground CRC outreach to build robust enrollment pipelines tailored to peripheral vascular, CLI, and endovascular patient populations.
- Advanced EHR query for targeted patient identification
- Community and referral network outreach
- Screen failure analysis and mitigation
- Patient retention and follow-up programs
Data Management & Quality Assurance
Audit-ready data from day one. ORCA's data management infrastructure ensures rigorous source document verification, EDC compliance, and real-time quality oversight throughout the trial.
- EDC setup and management
- Source document verification (SDV)
- Data query resolution
- Audit-ready record maintenance
Site Monitoring & Oversight
Proactive monitoring keeps trials on track and data clean. ORCA provides both on-site and remote monitoring services with real-time dashboards for site performance, enrollment, and protocol compliance.
- On-site monitoring visits
- Remote monitoring and data review
- Protocol deviation identification & CAPA
- Sponsor monitoring visit coordination
Study Closeout & Reporting
ORCA manages every step of trial closeout — from final data reconciliation and regulatory submissions to site archiving and sponsor deliverable handoff — ensuring a clean, compliant conclusion.
- Database lock and data reconciliation
- Regulatory closeout filings
- Final study report support
- Site archiving and document retention
Fast-Track MCTA Execution
ORCA's pre-negotiated master clinical trial agreement framework dramatically compresses contract timelines. Sites enter a master agreement that governs all future trials — eliminating months of legal back-and-forth for every new study.
- Pre-negotiated agreement templates
- Rapid legal review and execution
- Budget and payment schedule setup
- Multi-study master framework
Business Development & Trial Pipeline
ORCA actively cultivates sponsor and CRO relationships to create a continuous pipeline of research opportunities for its site network. Sites benefit from ORCA's industry connections without any business development overhead.
- Sponsor and CRO relationship management
- Trial opportunity matching via EHR-based site targeting
- Feasibility response support
- Site profile development for sponsors
Endovascular CRC Staffing
ORCA places trained, experienced cardiovascular and endovascular Clinical Research Coordinators directly at sites — either on-site or in a hybrid model — providing the human infrastructure that every trial requires.
- On-site & hybrid CRC placement
- Protocol-specific CRC training
- CRC performance oversight
- Workforce continuity planning
Therapeutic Specialization
Deep Expertise in Endovascular Trials
ORCA's services are purpose-built for the endovascular and peripheral vascular therapeutic space. Our team has deep operational expertise in the trial types, device categories, and patient populations that define this specialty.
Top Enroller
ORCA sites rank as top enrollers in multiple national endovascular trials
How We Deliver
Flexible Service Delivery Built Around Your Site
Every site is different. ORCA's service model is flexible by design — we adapt to your clinical environment, patient volume, and investigator availability, not the other way around.
Discuss Your NeedsOn-Site CRC Embedded Support
ORCA places a dedicated CRC at your facility — fully integrated into your clinical team — for sites with high trial volume or complex protocols.
Hybrid Remote + On-Site Model
For practices with lower trial volume, ORCA provides remote coordination with scheduled on-site visits — maximizing efficiency without unnecessary overhead.
Centralized Data & Regulatory Back-Office
Regardless of delivery model, ORCA's centralized regulatory and data team handles all submissions, EDC management, and monitoring remotely — ensuring consistency across every site in the network.
Scalable as You Grow
Whether you're running one trial or ten, ORCA's infrastructure scales with you — adding CRC support, regulatory bandwidth, and trial pipeline as your site grows.
Proven Track Record
Sponsors Who 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 Put These Services to Work?
Whether you're a clinical site ready to launch or a sponsor looking for faster enrollment, ORCA's full-service model is built to deliver.