QUALITY ASSURANCE

At ONDAX Scientific we believe that attention to detail and assurance of quality are fundamental components of our success as a Clinical Development company. To achieve this goal, we have developed quality assurance systems that are constantly evolving, allowing us to provide services that meet the highest quality standards.

The key role of our Quality Assurance Department is to ensure that all activities and services conducted on behalf of our clients are performed to the highest quality standards and in compliance with the current legislation, Good Clinical Practice guidelines, and Standard Operating Procedures (SOPs).

The Quality Assurance Department offers services ranging from the provision of complete QA services for Clinical Trials to individual services according to client requirements. The QA services include:

• Clinical study centre/investigational site audit

• Contract diagnostic laboratories audit
• Protocols and case report forms audit
• Clinical study documentation audit
• Trial master files audit
• Data Management audit
• Final Study Report audit

In addition to specific Clinical Trial services, our Quality Assurance Department can also assist in the following areas within the client's company:

• Training in GCP (VICH-GCP)
• Design and development of Standard Operating Procedures (SOP)
• Development and setting up Quality systems for Clinical Trials at your company
• Internal systems audit
• Quality Assurance (QA) consultancy