Clinical Trial Center Audits 

In the race to start and complete clinical trials, securing investigator, CRO, and sponsor GCP compliance can be an overwhelming task. Clinical quality audits are an essential tool in ensuring that clinical research is conducted in accordance with GCP requirements. Given the pressures of executing efficient and expedited research, including audits in your overall clinical investigative plan increases the quality of research data and protects sponsor investment. Addressing compliance issues early and consistently, through corrective and preventative action, enhances data integrity and the quality of the overall clinical trial.

Early audits can identify systematic problems in the conduct of a clinical trial. Corrective actions will immediately contribute to project management success.

External audits offer more guarantees for independence from company’s procedures and operational units.
Studies, service providers and systems are audited against international and national standards, namely ICH GCP and the Clinical Trial Directive 2001/20/EC and GCP Directive 2005/28/EC, the relevant parts of the FDA CFR and ISO 14155

Quality Management Systems

· Reviewing current structure and policies, processes and documentation

· Assistance in writing, reviewing, updating and adapting standard operating procedures (SOPs) to your specific needs and minimum requirements

· Establishing a comprehensive and efficient system enabling a consistent quality structure

· Identifying and initiating corrective and preventative actions to continually improve your processes

· Inspection Readiness Assessments

· Quality Systems Training, Development and Implementation

Training 3

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