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. goldbyte

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


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.

QA INSIGHT owned and managed by Rita Gabay. With clinical background, and M.Sc. in Quality Assurance and Reliability, Rita has over 20 years of experience in pharmaceutical, medical devices and in-vitro diagnostic industry: marketing, Clinical Quality Assurance (phase II to IV), and management of Quality Systems compliant with ISO 9001:2015 and 13485:2016.
Rita served as Quality Assurance Manager in International and Local pharmaceutical, medical devices and in-vitro diagnostic companies.
During her work Rita set up, implemented and maintained ISO (9001 and 13485) as well as GCP compliant Quality Systems; and performed vast range of 1st and 2nd party audits and Clinical Trials Audits (GCP and ISO 14155).
Rita lectures at the professional and educational forums on GCP , ISO and Medical Devices regulations
Rita is a certified auditor. She holds Certificate of International Register of Certified Auditors, and Medical Device Single Audit Program (MDSAP).
Among our clients are German Notified Body - mdc - Medical Devices Certification GmbH, well-known , worldwide CROs, as PAREXEL and Quintiles, and pharmaceutical companies - Gilead, J&J, Daiichi Sankyo and many others  
QA INSIGHT is fully committed to the client with professionalism as a fundamental business principle. The core of the process is achieving customer satisfaction by employing knowledge and experience. Our philosophy is simple: to offer excellence, integrity and reliability of performance in a straightforward, client-focused way. 
To create and maintain partnerships with customers; to provide client-oriented service at professional expert level applying high ethical standards; to ensure that our efforts are a profitable experience to our clients; to be recognized by client as a trusted partner.
Values – We believe that integrity and trust, experience and expertise, customer-oriented flexibility and truly personal service are the keys for success. We practice these values on every job.
Our motto is: The secret of success is constancy of purpose. Benjamin Disraeli.
Why to choose our services
QA INSIGHT Ltd. brings together skilled and experienced professionals with proven expertise in QA management and auditing in GCP, ISO 14155, ISO 9001 and 13485 areas.
With many years of experience covering Quality Systems management and auditing in clinical research departments and manufacturing facilities QA INSIGHT possesses all skills and capacities needed to provide independent, practical, professional and high-quality solutions for clients seeking for out-sourcing of auditing and QA consulting activities, all timely and at a very reasonable and competitive rate.
  • +972 52 6134368
  • P.O.Box 7746 Haifa, 3107701, Israel