Regulatory and Quality Assurance Services coordinate all activities on a global basis to ensure trials conducted by Covance Clinical Development on behalf of our clients always accurately follow strict regulatory guidelines and global quality standards. An international network of local regulatory leads further ensures that trials are conducted based on up to date knowledge of local regulations. This is to ensure patient well-being is always protected and data integrity maintained.
Regulatory Services collect, analyze and communicate intelligence on regulatory developments and requirements relative to clinical trials in all countries where Covance carries out Phase I-III human clinical trials. Regulatory Services also provides consultation on regulatory compliance issues and helps identify and support regulatory compliance training needs.
Quality Assurance and Compliance Services are focused on three main areas of audits:
-
Project audits, e.g. investigator files/site audits, trial master file audits, database audits, statistical report audits, clinical study report audits and regulatory submission audits
-
Process audits
-
Vendor audits
In all cases, the Quality Assurance Services lead liaises with all relevant project stakeholders regarding any quality issues, study status and planning of audits. Following the audit, audit reports identify issues for the responsible parties to resolve at the project level. If broader, systematic issues are identified, plans to resolve these issues are operationalized too.
Finally, follow up is put in place for all issues with a corrective action plan, and all critical and major issues are followed to resolution.
Additional services include:
-
Regulatory guidance and training on GCP
-
Quality metrics for management reporting
-
Investigator meeting support, e.g. presentations on GCP, common audit findings and handling regulatory inspections at sites
-
Regulatory inspection support, e.g. hosting inspections or preparing investigator sites for inspections
-
Standalone auditing service, including investigator brochures, protocols and informed consent forms (and amendments) and regulatory submission documents