| We constantly review and evaluate the clinical trial process to guarantee performance excellence and adherence to testing protocols.
Learn more about CCT’s strategies for reducing study failure:
GOOD CLINICAL PRACTICES (GCPs)
QUALITY ASSURANCE OPERATIONS
QUALITY ASSURANCE PROCESSES
Good Clinical Practices (GCPs)
Whether it's designing studies, recruiting subjects, or collecting, recording and reporting data, we protect the safety of our human subjects and utilize clinical operating guidelines that meet or exceed GCP, and assure patient confidentiality (HIPAA compliant).
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Quality Assurance Operations
We plan and perform ongoing QA activities to ensure that our trials are performed ethically and that they rigorously adhere to protocol. Prior to randomization in an early drug development study, the Clinical Research Coordinator and Research Associate prepare all needed flow charts and source document forms. These forms are carefully reviewed by the investigator and by our QA department prior to the randomization of the first patient. All patient screening data is also reviewed to ensure no protocol violations for inclusion or exclusion criteria have been inadvertently overlooked.
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Quality Assurance Processes
Once patients complete a protocol, our independent QA teamreviews data tabulation and clinical report forms (CRFs) for accuracy and precision.
For Phase II-IV trials, we internally audit the first patient's CRFs and perform subsequent 'spot checks' throughout the study. CCT pre-reviews all charts in anticipation of upcoming audits from either the Sponsor or regulatory agencies.
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Contact our staff for more information on CCT’s Quality Assurance program | 
