Clinical Trial Leadership Without the Barriers
Hands-on, efficient consultancy that works within your existing framework.
Medical Device & Pharmaceutical Clinical Trials
Built to Integrate, Not Replace
COR Clinical Research delivers senior-level clinical project management and operational leadership for medical device and pharmaceutical clinical trials at any stage—without the layers and limitations of more rigid service models.
Designed to work within existing systems and standard operating procedures (SOP), COR integrates seamlessly alongside internal teams and external partners. That means no lengthy onboarding, no retraining, and no replacement of existing study infrastructure—just experienced leadership, ready to step in.
Because every community deserves a cure.
At COR, we understand the operational barriers that often limit when and where clinical trials are conducted. Our integration-first approach reduces the complexities that stand in the way of access—bringing experienced leadership into existing environments so studies can reach more patients, faster.
COR Services
From early planning through close-out, COR provides flexible, hands-on support tailored to the needs of each study—filling gaps, stabilizing operations, and ensuring trials maintain momentum.
Whether through consulting services or an integrated functional service provider (FSP) model, COR operates in alignment with FDA regulations and Good Clinical Practice (GCP) standards—supporting compliant, high-quality trial execution.
Clinical Project Management
End-to-end trial management (First-in-Human to Phase IV)
Timeline, budget, and scope management
Study plan development (project, monitoring, risk, and communication)
Risk identification and mitigation planning
Cross-functional leadership and communication
Short- and long-term functional coverage (PM, CTM, CRA)
Rescue management for at-risk studies
Global trial coordination across complex, multi-site studies
Decentralized and hybrid trial operational support
Medical device trial management (IDE, PMA, post-market)
Pharmaceutical trial management (NDA)
Vendor/CRO selection and oversight
Study Start-Up
Global feasibility and site selection
Protocol, ICF, and essential document review
Regulatory submission support (FDA, IRB/EC, Health Authorities)
Timeline development and oversight
Collaborative team leadership
Streamlined site contract and budget negotiation
Site Management & Monitoring Oversight
Monitoring strategy development
Review of monitoring reports and site health
Issue escalation, action planning, and close-out
Enrollment strategy development and rescue support
Screening and enrollment tracking
Efficient communication pathways across sites and stakeholders
Clinical Operations & Quality Support
Clinical research monitoring (remote and in-house)
Data review and submission prep
Strategic clinical trial management
Quality Support
SOP development and review
Inspection readiness
Training programs
Strategic & High-Value Services
Portfolio-level oversight
Operational process optimization
Forecasting and resource planning
Budget modeling and scenario planning
Audit readiness and quality improvement initiatives
Physical Therapy Protocol Advisory
DPT-led protocol review and development
Functional outcomes strategy for device and pharmaceutical trials
Pre- and post-intervention care guidance for joint and limb replacement studies
Rehabilitation considerations for post-stroke and neurological trials
Alignment of functional endpoints with clinical and operational goals
Protocol support reflecting real-world recovery and patient needs
When COR Can Help
COR is a strong fit when sponsors, clinical sites, or CROs need experienced leadership without added complexity, including when:
A study needs to move quickly
Teams need senior-level or temporary support
A program is at risk due to operational gaps
Sponsors, clinical sites or CROs need added oversight
Trials are expanding into new or underserved communities