Itec services

Map iso 9001 certification

  Realization process
  Quality System Management
  Business Process

 

Scientific Director

• Ensure that quality management procedures exist, implement them and see they are maintained;
• Report quality status to the Directors and alert them about necessary improvements;
• Make collaborators aware of quality obligations.

Quality Manager

• Advise and help Heads of Operations (Director of Clinical Studies, Director of Epidemiological Studies, Data Management Director, Business Development Manager) in setting up quality procedures;
• Implement corrective actions and improvements;
• Test current diagnostic practices and audit procedures;
• Promote discussion on quality practices.

Heads of Operations

(Director of Clinical Studies, Director of Epidemiological Studies, Data Management Director, Business Development Manager)

• Have direct access to both the Scientific Director and Quality Controller;
• Supervise operations, ensure that study results are concordant with study aims, and check that resources are used efficiently.

Project Head

• Responsible for studies and attainment of contractual objectives;
• Implement procedures in the protocol and demanded by Sponsor;
• Relay quality awareness;
• Provide feedback on the project during its execution.

Other parties involved

(Clinical Research Assistants, Epidemiological Research Assistants, Clinical Study Managers, Epidemiological Study Managers)

• Signal malfunctions and suggest remedies;
• Implement quality procedures;
• Contribute to achieving contractual objectives;
• Listen to what investigators and sponsors say and pass on the information.

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