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Quality Assurance Audits
As well as being an integral part of our internal processes, Novotech is able to provide a full range of independent Quality Assurance services from pre-clinical, through phase I to phase IV studies on an international basis. Our QA department is staffed by experienced professionals operating independently from the personnel engaged in the management and conduct of clinical trials.
Quality Assurance audits encompass all aspects of the clinical development process, including:
• Trial Master File Audits
• Investigator Site Audits
• Phase I Units
• Clinical Research Organisations
• Other vendors (e.g. archive facilities, Investigational Product management
 and storage)
• Study Documentation e.g. Protocols, Clinical Study Reports
• Systems Audits
• Computer System Validation Reviews
• Local, Central and Bioanalytical Laboratories
• Database Audits
• GLP Audits
• Bioanalytical Method Validation
In addition, Novotech is able to provide support and advice on the following:
• Quality System Management
• SOP Development
• Due Diligence
Our auditors have extensive auditing experience in various types of audits. Audits have been performed for a wide range of indications and in various countries e.g. USA, Canada, South America, Western, Central and Eastern Europe, India, Thailand, Australia and New Zealand. |
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