Device and Diagnostic Clinical Trials

We understand that Medical Device and IVD trials are markedly different from those for pharma, and call for very different approaches.

We are adept at managing a complete clinical trial program or a specific project and have detailed knowledge of clinical evidence regulatory requirements for Australia, USA, Asia and Europe. We are as skilled in modern biotechnology as we are in regulatory process.

Our Services include:

• Global Clinical Program Strategy
• Clinical Trial Design and Planning
• Ethics Submissions and Regulatory Affairs
• Monitoring and Project Management
• Biostatistical Analysis and Data Management
• Medical Writing and Reporting
• Software Development
• Training

Your product will face many regulatory hurdles and risks throughout its development cycle. Talk to Brandwood Biomedical – the Medical Device and IVD CRO with professionalism and specialist expertise that complements your own.

For more information about our capabilities and staff, please contact us direct on (02) 9906 2984 or Submit Online Inquiry