Phase II-IV
Experience, Scale and Speed for Late-Phase Clinical Research
An integrated model for late-phase clinical trials, bringing together experienced investigators, dedicated research professionals, an established patient population, and specialized operational infrastructure.
For more than 30 years, NECCR has conducted Phase II, III and IV clinical trials across a broad range of therapeutic areas.
Our independent research structure combines the resources and patient access of a large multispecialty medical network with the responsiveness of a dedicated clinical research site—helping sponsors and CROs move studies from feasibility through activation and enrollment efficiently.
Built to Move Clinical Research Forward
NECCR operates independently from academic and hospital systems, allowing our clinical, regulatory and operational teams to work directly with sponsors and CROs without many of the administrative layers associated with large institutions.
Our integrated model brings together experienced investigators, dedicated research professionals, an established patient population and specialized operational infrastructure.
Rapid Study Startup
Our dedicated infrastructure allows regulatory, contracting, feasibility and recruitment planning to progress in parallel.
NECCR averages approximately two weeks from protocol receipt to site readiness, depending on study requirements.
Our startup process includes:
- Rapid protocol and feasibility assessment
- Streamlined CDA, CTA and budget processes
- Central IRB submission and coordination
- Early patient database analysis and pre-screening
- Site Initiation Visit preparation
- Staff protocol training
- Patient recruitment planning and activation
A Longitudinal Patient Population of 200,000+
Dedicated Clinical Research Infrastructure
Specialized Teams Supporting Every Stage of the Trial
NECCR uses a specialized departmental model rather than requiring individual coordinators to manage every administrative and clinical function.
This allows each team to focus on its area of expertise while working together throughout the study lifecycle.
Regulatory
Dedicated regulatory specialists coordinate essential study documentation, Central IRB submissions, financial disclosures, Form FDA 1572 documentation and ongoing regulatory requirements.
Patient Recruitment
Dedicated recruiters focus on patient identification, pre-screening, outreach and enrollment support using both data-driven and community-based recruitment strategies.
Research Coordination
Clinical research coordinators focus on protocol execution, patient visits, safety monitoring, data entry and timely EDC query resolution.
Information Technology
Quality and Compliance
Experienced. Audit-Ready. Built Around Data Integrity.
For more than three decades, NECCR has maintained clinical research operations designed around patient safety, protocol compliance and high-quality data.
Our Standard Operating Procedures are maintained in accordance with applicable FDA requirements, ICH-GCP guidelines and regulatory standards.
Our research operations support:
- Timely and accurate clinical data entry
- Responsive EDC query management
- Comprehensive regulatory documentation
- Ongoing patient safety monitoring
- Sponsor and CRA monitoring requirements
- Established quality-control processes
Site Capabilities
Our clinical research infrastructure includes:
- Temperature-monitored, restricted-access investigational product storage
- On site laboratory
- -20°C and -80°C cold storage
- Continuous digital temperature monitoring
- Dedicated monitoring space for Clinical Research Associates
- High-speed connectivity
- Technology infrastructure supporting sponsor platforms and systems
Rapid, Data-Informed Feasibility
NECCR provides sponsors and CROs with timely feasibility assessments supported by direct access to our clinical and patient network.
Feasibility questionnaires can typically be completed within 24–48 hours, supported by targeted patient database queries and input from relevant investigators.
A centralized clinical operations and business development team coordinates feasibility, contracting, budgeting and study startup to provide sponsors with a clear point of contact throughout the process.