The clinically specialised team at Five Corners has extensive experience in clinical research and understands the obligations a Local Sponsor has in acting on behalf of an international medical device partner company. As a Local Sponsor, the team at Five Corners is able to provide:

• Study Protocol Development
• Study CRF Development
• Statistical Plan Development
• Investigator Brochure Development
• Study Budget Development
• Site Identification
• Site Qualification
• Site Contract Negotiation
• Regulatory Document Management
• Regulatory Notifications of Studies and Serious Adverse Events (where required)
• Preparation of HREC submissions and amendments
• Investigator Meeting Preparation
• Site Initiation
• Study Monitoring
• Site Management
• Subject Recruitment Support
• Medical Report Writing
• Site Payment Management
• Trial Master File Management
• Overall Study Project Management
• Facilitating HREC Serious Adverse Event Reporting with Investigators
• Investigational Device Storage and Management
• Study Close Out

With both Australia and New Zealand recognised as Tier One Countries, clinical data collected from human studies in these countries is able to be used to support CE Mark Submissions in the EU as well as 510(k) and PMA Applications in the US.

Our services will be tailored to your needs depending on the current stage of development of your company, your product and your study. Being a boutique clinical research organisation allows flexibility in our approach to meeting your needs.

Key to a successfully executed clinical study is developing an early relationship with the clinical trial sites; not only the Principal Investigator, but all of the Study Team. Leveraging from extensive clinical experience, the team at Five Corners is highly experienced in developing and maintaining working relationships with all study staff, acting as a bridge between the manufacturing sponsor and the researcher. This is a critical element of early study activation, speedy but effective recruitment, diligent and timely subject follow-up, and expeditious data entry.