Our services
Our team of research specialists provide an end-to-end clinical trials service.
Researchers and industry partners can utilise any or all of the services below:
- Concept development
- Protocol design and writing
- Funding applications
- Budget and costing
- Contract advice
- Sample size calculation (in conjunction with the Statistics Consultancy Platform)
- Health economic impact analysis
- Support for public involvement
- Identifying clinical trial sites
- Advice on Research Infrastructure
- PRIME researcher portal.
- Ethics advice
- HREC and Governance submissions
- Response to HREC queries
- Contract facilitation
- Indemnity and Insurance
- Standard Operating Procedures
- Good Clinical Practice (GCP) training
- Data Safety and Monitoring Boards (DSMBs)
- Monitoring and reporting of Adverse Events
- Annual reporting
- Breach reporting
- Corrective and Preventative Action (CAPA) implementation
- PRIME researcher portal.
- Database design and build
- Randomisation service
- Data queries
- Data extract, linkage and database integration
- Data cleaning and preparation for analysis
- Source data document templates
- Advice on data management and storage
- Data sharing
- Connecting to open science (including standardised open access, machine readable data reporting - STARDIT).
- Desktop monitoring
- Risk-based monitoring
- Preparation for audits and regulatory inspections.
- Statistical analysis of trial data (in conjunction with the Statistics Consultancy Platform)
- Endpoint adjudication
- Independent safety monitoring.
- Protocol tools and templates
- Template documents- CV, delegation and training Logs
- Investigator Site File (ISF) templates
- Trials Methodology Seminar Series
- Information on upcoming conferences and events.
- Set up and review of Investigator Site File (ISF)
- Creation of investigator training packages
- Organise and facilitate investigator training
- Support for the inclusion of CALD communities
- Advertising and promoting trials
- Trial registration
- Monitoring participant recruitment and protocol compliance
- Organising and hosting events – ie. focus and consultation groups, round tables
- Archiving of study documentation.