Clinical Quality Management
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.
GCP 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 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.
ISO Quality Management
We offer ISO consulting programs to assist you in developing and implementing an effective Quality Management System (QMS) that meets the requirements of ISO 13485, Council Directive 93/42/EEC for CE marking of medical devices, the FDA QSR and Canadian Medical Device Regulations (MDR).
We provide a full range of services such as:
• Development and implementation of new QMS
• Upgrade or optimization of your existing QMS to establish compliance
with additional standards
• Conduct second party audits, including pre-certification audits
• Development and implementation of documentation systems
• Assistance in certification audits
Training
Training sessions by QA INSIGHT Ltd.
• Introduction to ISO 9001 and 13485 standards
• Preparation to audit of Health Canada (CMDCAS and Canadian MDR)
• Medical Devices Regulations all over the world – basics
• ISO 13845 and Medical Devices Regulations
• ISO 13485 Internal Auditors Training
• Design & Development Controls
• Good Clinical Practice (modular course for sponsors and investigators)
• Good Clinical Practice and system Quality Assurance for Clinical
Research Organization
• Good Clinical Practice (GCP) Auditing (modular course for QA professionals and investigators)
and MORE