BRIDGE THE COMPLIANCE GAP

Values

 

 

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

Vision

 

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.

 

Philosophy



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

 

 

What is Good Clinical Practice (GCP) and ISO 14155?

 

Definition from EU Directive 2001/20/EC, article 1, clause 2:

 

      “Good clinical practice is a set of internationally recognized ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.”

SO 14155:2011 is titled:

Clinical investigation of medical devices for human subjects - Good clinical practice" 

 

The new standard appears to be largely harmonized with ICH clinical study guidelines. It addresses the technical aspects of clinical investigations carried out in human subjects to establish the performance and safety of medical devices for regulatory purposes by defining procedures for their design, conduct, recording and reporting.
 

 

 

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