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CNS CRO
Quality Assurance
QUALITY ASSURANCE
EXCELLENCE IN CNS TRIALS
At CRC, Quality Assurance is the foundation of our clinical research philosophy. Our entire organization regards quality as a dynamic, strategic discipline: predictive rather than reactive, integrative rather than siloed. Anchored in a rigorous, risk-based, and neuroscience-optimized Quality Management System (QMS), our approach exceeds regulatory compliance to foster a culture of rigor, transparency, and ethical accountability, ensuring that every study we conduct withstands regulatory scrutiny and earns the trust of investigators and sponsors.
DISTINCTIVE FEATURES OF OUR CNS-FOCUSED QMS
01.
Purpose Built for Neuroscience
Our QMS is designed to address the scientific and operational nuances of CNS trials, including subjectivity in endpoints, variability in rater performance, and the inclusion of vulnerable populations. CRC applies proportional and flexible controls that align with the therapeutic and clinical goals of each study.
02.
Embedded Quality by Design (QbD)
CRC applies QbD principles from study planning through execution, enabling early risk identification and integrated mitigation strategies, which are essential for complex CNS programs.
03.
Risk-Based Oversight
CRC ensures consistent data integrity and participant safety. Our QMS includes specialized controls for cognitive, behavioral, and psychiatric assessments and aligns with regulatory expectations.
REGULATORY
PERFORMANCE
In 2025, a pre-approval FDA inspection of a sponsor and four investigational sites, where we provided rater training, project management, monitoring, and data management, concluded with no Form 483 observations. This outcome reflects our consistent regulatory excellence. Additionally, an FDA inspection of CRC in 2017 resulted in no observations, confirming our longstanding commitment to quality and compliance in CNS clinical research.
QA SERVICES TAILORED FOR CNS SPONSORS
CRC provides a comprehensive suite of Quality Assurance services that support inspection readiness and program integrity across every phase of a CNS trial.
01.
Vendor Qualification
Comprehensive evaluations to ensure vendors meet both regulatory and therapeutic expectations.
02.
Site Audits
Thorough reviews of site conduct, documentation, and participant safety, with emphasis on challenges specific to CNS trials.
03.
QMS Development & Optimization
Strategic consulting to help sponsors design or refine QMS frameworks that reflect the scientific and operational complexity of neuroscience studies.
04.
Inspection Readiness & Support
Preparation and real-time support during regulatory inspections, with a focus on CNS-specific documentation, data integrity, and compliance.
05.
System Validation Support
Validation of electronic systems, e.g., eCOA, EDC, and IRT.
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