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Providing independent Quality Assurance services by highly experienced professionals, across all clinical trial phases. 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.

Available internationally, a Novotech clinical trial audit ensures high ethical standards of clinical trials are upheld and minimizes risk to data integrity.

Our QA department is staffed by experienced professionals who operate independently from the personnel engaged in the management and conduct of clinical trials.

Quality Assurance services encompass all aspects of the clinical development process, including:

Trial Master File Audits Investigator Site Audits
Phase I Units Systems Audits
Third party vendors including archive facilities, Investigational Product management and other CROs Study Documentation e.g. Protocols, Clinical Study Reports
Computer System Validation Reviews Local, Central and Bioanalytical Laboratories
Database Audits GLP Audits
Bioanalytical Method Validation Quality System Management
SOP Development Due Diligence
> Biostatistics
> Data Management
> Quality Assurance
> Medical Writing
> GIS Mapping
All those planned and systematic actions that are established to ensure that the trial is performed and the data is generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).
 

 

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