Clinical Quality Management

Vendors /CROs /Clinical amp; Specialty Lab Audits amp; Assessment (2b)

With many years of experience as QA and CQA and knowledge of ISO 15189 we offer system audits of Sub-Contractors, Vendors, Clinical Research Organizations and Clinical amp; Specialty Laboratories operations and systems to assess facilities, equipment, and personnel qualifications, client satisfaction, conformance with SOPs, and regulatory compliance

Actions to continually improve your processes

• Inspection Readiness Assessments
• Quality Systems Training, Development and Implementation

Clinical Quality Management activities will allow planning for effective protocol implementation, assure compliance with sponsor requirements, identify areas in need of corrective action, verify the accuracy of data, and assure a constant state of readiness for an external audit.

Clinical Quality Assurance is a periodic, systematic, objective review of trial-related activities to ensure that the trial is performed and the data are generated, documented and reported in compliance with Good Clinical Practice (GCP) and any applicable regulatory requirements.

The development and implementation of a CQM that addresses key aspects of clinical research activities will help ensure that the rights and safety of participants are protected and that data collected are accurate and complete.

WE can assist you in managing your quality management systems, by: (1a)

• 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

AUDITING SERVICES

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 companyrsquo;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 and the relevant parts of the FDA CFR.