CAP Accredited, ISO 15189 certified, CLIA accredited, and supported by quality systems aligned with GCLP, GMP, and regulatory expectations
Quality is an integral part of every department at Navigate BioPharma with a focus on continuous improvement and a commitment to excellence. Our BioPharma’s Quality Systems are designed and maintained to:
- Assess and continuously improve the delivery of services to meet the needs of patients and sponsors of clinical trials for drug and diagnostic applications
- Evaluate and improve the reliability, efficiency, and quality of our services
- Identify, and minimize sources of errors, problems, and complaints
- Provide a mechanism for corrective and preventive actions
- Assess and ensure the effectiveness of our policies
- Ensure the adequacy and competency of our staff
- Ensure the integrity of our data
- Ensure compliance with applicable regulatory requirements for drug and diagnostic approvals, including CLIA, Good Clinical Practice/Good Clinical Laboratory Practice (GCP/GCLP), Good Manufacturing Practices (GMP), and Quality System Regulations (QSR)
Navigate BioPharma has CLIA (Clinical Laboratory Improvement Amendments) accreditation for high complexity testing through CMS (Centers of Medicare and Medicaid Services) and participates in the College of American Pathologists (CAP) Laboratory Accreditation Program.
Navigate BioPharma also maintains current licensure required by state and local regulations.
Navigate BioPharma Accreditations
Navigate BioPharma is CAP/CLIA accredited along with specific state licensed: CA, NY, PA, MD, RI and FLA.
Most recent CAP Inspection was in November 2024 and is conducted every two years. Additionally, our Quality Management System is compliant with GCP, GCLP, and GMP regulations. Navigate also has a California Manufacturing License.
The FDA conducted a successful bioresearch monitoring (BIMO) inspection of our facility in early 2019 for a companion diagnostic program where Navigate BioPharma supported the clinical and analytical validation.
Please contact our team to schedule a sponsor audit.
Frequently Asked Questions About Quality Assurance
What is quality assurance in clinical trial laboratory testing?
Quality assurance (QA) is a systematic approach to ensuring laboratory processes, data generation, and testing activities consistently meet predefined quality standards and regulatory requirements. At Navigate BioPharma, quality is integrated into every department through established quality systems, continuous improvement initiatives, and a commitment to generating reliable clinical trial data.
Why is quality assurance important for clinical trials?
Quality assurance helps ensure that clinical trial data are accurate, reliable, reproducible, and suitable for regulatory decision-making. Strong QA processes help sponsors minimize risk, reduce errors, maintain compliance, and support successful drug and diagnostic development programs. Navigate's quality systems are specifically designed to improve service delivery, data integrity, operational efficiency, and regulatory compliance.
What quality standards and regulations does Navigate BioPharma follow?
Navigate BioPharma maintains quality systems designed to support compliance with applicable regulatory requirements, including Clinical Laboratory Improvement Amendments (CLIA), Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Good Manufacturing Practices (GMP), and Quality System Regulations (QSR). These systems help ensure the integrity, reliability, and regulatory acceptability of clinical trial data.
Is Navigate BioPharma CAP accredited and CLIA certified?
Yes. Navigate BioPharma maintains CLIA accreditation for high-complexity laboratory testing, participates in the College of American Pathologists (CAP) Laboratory Accreditation Program and is ISO 15189 accredited. The organization also maintains applicable state licenses required by regulatory authorities
How does Navigate ensure data integrity in clinical trials?
Navigate's quality systems are designed to ensure data integrity through documented processes, quality oversight, staff training, corrective and preventive action (CAPA) programs, policy reviews, and continuous quality monitoring. These controls help sponsors maintain confidence in the accuracy, consistency, and traceability of laboratory data generated throughout clinical development.
What is a corrective and preventive action (CAPA) program?
A corrective and preventive action (CAPA) program is a quality management process used to identify issues, investigate root causes, implement corrective actions, and prevent future recurrence. Navigate incorporates CAPA processes within its quality system to identify, address, and minimize sources of errors, problems, and complaints
How does Navigate support sponsor audits and regulatory inspections?
Navigate routinely supports sponsor audits and maintains quality systems designed to support regulatory readiness. The organization has experience supporting programs associated with major regulatory submissions and maintains comprehensive documentation, oversight processes, and quality controls that facilitate sponsor and regulatory inspections.
Has Navigate BioPharma successfully supported FDA-regulated programs?
Yes. Navigate has supported programs associated with FDA-regulated submissions, including companion diagnostic programs requiring clinical and analytical validation. The company reports successful FDA bioresearch monitoring (BIMO) inspection experience related to a companion diagnostic development program.
How does Navigate maintain laboratory staff competency?
Navigate's quality systems include procedures designed to assess and ensure staff competency, maintain training requirements, and support continuous quality improvement. These processes help ensure testing is conducted consistently and according to established quality standards.
What quality systems does Navigate use to support biomarker and bioanalytical testing?
Navigate applies quality systems across its biomarker, flow cytometry, genomics, digital pathology, and ligand binding laboratory operations. These systems are designed to improve reliability, efficiency, data integrity, and compliance while supporting both exploratory and regulated clinical development programs.
How does Navigate BioPharma ensure continuous quality improvement?
Continuous improvement is a core component of Navigate's quality culture. Quality systems are designed to regularly assess service delivery, evaluate operational effectiveness, identify potential sources of error, implement improvements, and measure the effectiveness of policies and procedures over time.
Why choose Navigate BioPharma as a quality-focused laboratory partner?
Navigate BioPharma combines CAP and CLIA accreditation, established GCP/GCLP/GMP quality systems, regulatory inspection experience, sponsor audit support, and a company-wide commitment to quality. These capabilities help sponsors generate reliable, compliant data that can support clinical development, companion diagnostics, and regulatory submissions.