Clinical Studies
We establish and co-ordinate clinical and marketing studies for the purposes of product development, device regulatory and reimbursement purposes. This encompasses evaluations ranging from Phase I / Phase II (basic safety and efficacy) through Phase III (randomised controlled trials) to Phase IV (post marketing studies). We can conduct these studies in countries as diverse as Japan, Australia, New Zealand, South Korea, India and China, depending on your needs.
We are a Contract Research Organisation (CRO) that implements and co-ordinates all aspects of clinical studies, including:
- Protocol development and writing.
- Affiliation with medical biostatistical services.
- Related document creation including Patient Information Sheets and Case Report Forms.
- Preparation of Ethics Committee and associated documentation, including budgeting and advice on insurance requirements.
- Clinical trial notification and ongoing communication with relevant clinical and regulatory bodies.
- Importation, storage and device accountability of equipment used in clinical studies.
- Investigative site initiation documentation.
- Training of clinical site study personnel.
- Ongoing technical support.
- Procedural attendance to ensure accurate collection of peri-operative data.
- Monitoring and Auditing of data as required.
- Data entry and on-going data management.
- Preparation of abstracts and manuscripts for presentation and publication.