Clinical Pathways
Clinical Pathways, LLC is a consulting and training firm dedicated to providing high-quality, affordable clinical research services. They specialize in clinical trial consulting, training, and quality systems support, aiming to help clients handle complex clinical research trials efficiently and professionally. Their mission is to deliver customized services that promote best practices in clinical research, with a focus on quality, safety, and compliance.
Industries
Nr. of Employees
small (1-50)
Clinical Pathways
Chapel Hill, North Carolina, United States, North America
Products
Course catalog (PDF)
Downloadable catalog listing available courses and training solutions for clinical research professionals (includes ICH E6, monitoring, risk management topics).
Off-the-shelf eLearning courses (store)
Prebuilt online courses covering monitoring, HIPAA/EHR monitoring, risk-based monitoring, SDV vs SDR, and GCP topics available for individual purchase or enterprise licensing.
ICH E6(R3) GCP training (comprehensive)
Comprehensive training materials and courses focused on changes from ICH E6(R2) to ICH E6(R3) and related GCP expectations for busy clinical research professionals.
Consulting services one-pager (PDF)
Overview document summarizing offered consulting services including inspection readiness, auditing, quality systems, risk management and monitoring.
Course catalog (PDF)
Downloadable catalog listing available courses and training solutions for clinical research professionals (includes ICH E6, monitoring, risk management topics).
Off-the-shelf eLearning courses (store)
Prebuilt online courses covering monitoring, HIPAA/EHR monitoring, risk-based monitoring, SDV vs SDR, and GCP topics available for individual purchase or enterprise licensing.
ICH E6(R3) GCP training (comprehensive)
Comprehensive training materials and courses focused on changes from ICH E6(R2) to ICH E6(R3) and related GCP expectations for busy clinical research professionals.
Consulting services one-pager (PDF)
Overview document summarizing offered consulting services including inspection readiness, auditing, quality systems, risk management and monitoring.
Services
Consulting to prepare organizations for regulatory inspections across clinical GxP and EMA contexts, including readiness assessments and simulation.
Execution of GxP audits of vendors, sites, systems and documentation with formal reports and follow-up recommendations.
Design and update of SOPs, documentation control, training programs, QC/QA practices, and system validation strategies to mature clinical quality systems.
Facilitation of risk assessments, development of risk mitigation plans, and performance improvement activities integrated into study management.
Provision of experienced monitors and auditors to augment clinical monitoring and QA functions, supporting on-site and remote monitoring activities.
Development and delivery of tailored GxP/GCP training for enterprise audiences across roles, including curriculum design and training delivery in multiple formats.
Consulting to prepare organizations for regulatory inspections across clinical GxP and EMA contexts, including readiness assessments and simulation.
Execution of GxP audits of vendors, sites, systems and documentation with formal reports and follow-up recommendations.
Design and update of SOPs, documentation control, training programs, QC/QA practices, and system validation strategies to mature clinical quality systems.
Facilitation of risk assessments, development of risk mitigation plans, and performance improvement activities integrated into study management.
Provision of experienced monitors and auditors to augment clinical monitoring and QA functions, supporting on-site and remote monitoring activities.
Development and delivery of tailored GxP/GCP training for enterprise audiences across roles, including curriculum design and training delivery in multiple formats.
Expertise Areas
- Clinical trial operations
- GCP/GxP compliance and auditing
- Quality systems development for clinical research
- Quality risk management (QRM) and risk-based monitoring
Key Technologies
- Remote monitoring of electronic health records and source documents
- eLearning platforms and webinar delivery
- Risk assessment tools and risk indicators
- Liquid (metrics-driven) monitoring report methodology
News & Updates
In February 2025, the FDA and HHS OHRP released the final guidance on IRB written procedures.
A training designed for professionals to deepen their knowledge on GCP standards.
FDA published a draft guidance on the use of AI in drug and biological product regulation.
EMA released a reflection paper on the use of RWD in NIS to generate RWE for regulatory purposes.
In February 2025, the FDA and HHS OHRP released the final guidance on IRB written procedures.
A training designed for professionals to deepen their knowledge on GCP standards.
FDA published a draft guidance on the use of AI in drug and biological product regulation.
EMA released a reflection paper on the use of RWD in NIS to generate RWE for regulatory purposes.