Expert management of clinical trials for medical devices and in vitro diagnostics.

George Clinical provides specialist medical device and diagnostics product trial experience in the following areas:

• Pilot studies
• Feasibility studies
• Pivotal studies that are designed to collect definitive safety and efficacy data
• Clinical investigations to support development and submission for Class II and III devices
• Post-market studies to identify trends in outcomes, design and usage

George Clinical brings its experience in trial delivery to the medical devices area, delivering quality outcomes and cost-effective solutions to our sponsors. As a specialized CRO in Asia-Pacific and the USA we are well placed to access the large patient populations through our extensive site networks.

Why George Clinical?

• George Clinical provides a high-level of flexibility and adaptability, while offering access to an extensive global footprint and infrastructure
• High quality systems and processes for full service delivery including safety management and data collection
• George Clinical has experience conducting some of the largest device trials ever conducted in the region, the SAVE trial being a recent example
• In-house, independent quality management, auditing and assurance
• Highly experienced project teams
• Dedicated medical and feasibility teams
• A dedicated suite of e-solutions to provide timely and accurate site, sponsor and CRO communications

Our clinical trial services in medical device clinical trials include:

• Program / Protocol Design
• Scientific Leadership
• Project Management
• Clinical Monitoring
• Regulatory Services
• Medical Monitoring
• Safety Services including Endpoint Adjudication and DSMBs
• Data Management
• Statistics
• Health Economics