Nor Consult
Nor Consult, LLC is an independent full-service Contract Research Organization specializing in the clinical research of medical devices, drugs, and combination products. Founded in 2005, it manages global multi-center trials across various therapeutic areas, with a focus on excellence in study design, management, and regulatory strategies. The company collaborates with leading scientists and clinicians worldwide, offering services in clinical research, regulatory affairs, and medical writing to support sponsors in achieving broad regulatory approvals and successful clinical trials.
Industries
Nr. of Employees
small (1-50)
Nor Consult
Seattle, Washington, United States, North America
Services
Creation of clinical investigation plans, protocols, informed consent forms and related regulatory documents for device, drug and combination product studies.
Comprehensive trial management including site coordination, vendor management, monitoring oversight and multi-region project delivery.
Monitoring services to ensure protocol compliance, data quality and regulatory adherence at investigator sites.
Deployment and management of electronic data capture, secure image collection/archiving, and compliant data warehousing to support study data workflows.
Design and execution of statistical analysis plans, advanced biostatistical methods and adaptive design implementations for clinical trials.
Preparation and strategy for submissions to global regulatory agencies and ethics committees for device, drug and combination products.
Creation of clinical investigation plans, protocols, informed consent forms and related regulatory documents for device, drug and combination product studies.
Comprehensive trial management including site coordination, vendor management, monitoring oversight and multi-region project delivery.
Monitoring services to ensure protocol compliance, data quality and regulatory adherence at investigator sites.
Deployment and management of electronic data capture, secure image collection/archiving, and compliant data warehousing to support study data workflows.
Design and execution of statistical analysis plans, advanced biostatistical methods and adaptive design implementations for clinical trials.
Preparation and strategy for submissions to global regulatory agencies and ethics committees for device, drug and combination products.
Expertise Areas
- Clinical trial management
- Regulatory submissions and strategy
- Biostatistics and adaptive design
- Medical writing and regulatory documentation
Key Technologies
- Electronic data capture (EDC)
- Secure clinical image archiving
- Adaptive statistical design methods
- Biostatistical analysis
News & Updates
In 2019, Nor Consult managed its first FDA QIDP trial, expanding its expertise in infectious disease research.
In 2019, Nor Consult managed its first FDA QIDP trial, expanding its expertise in infectious disease research.