Clinical Trials.

Mobius Medical manages a wide variety of clinical trials for both our local and international partners.

From monitoring a single Australian centre as part of a multi-national trial, to acting as the Australian Sponsor for large, regional, pivotal trials, Mobius has the expertise and resources for virtually all of your clinical trial requirements.

The integral clinical team of Mobius Medical have over 17 years working in clinical research, a vast proportion of that time specifically in the area of medical device development.

Clinical trial management can encompass entire projects, from strategic design advice to clinical report production, or specific individual tasks, such as monitoring.

 

The range of services we offer, tailored to your specific needs

• Strategic advice for development of clinical investigational plan
• Development of key objectives of trial data (regulatory and commercial)
• Clinical trial document development
• Investigational Plan
• Investigator’s Brochure
• Monitoring Plan
• Case Report Forms/data collection tools
• Development of statistical plans, advice on databases and output
• Clinical trial budgets, planning, negotiations
• Key Opinion Leader identification
• Site identification, qualification, initiation and training
• Investigator meeting planning and execution
• Clinical Investigation Research Agreements and legal document preparation
• Trial Master File compilation and management (paper and electronic)
• Preparation of HREC submissions and amendments
• Notification and liaison with regulatory bodies
• Site Management
• Patient recruitment support/strategy
• Monitoring
• Query resolution
• Site staff relations
• Medical oversight (safety reporting and regulatory compliance)
• Report writing
• Investigational product management
• Study close out
• Archiving