Services Offered
The Centre offers extensive research support services for clinical trials, epidemiological studies and other medical studies in the areas of biostatistics, data management, data processing, software development and project management.
Biostatistics
- Statistical analysis and reporting to regulatory standards
- Participation in study committees and regulatory meetings
- Publication and presentation of study results
- Statistical advisory consultation service
Study Design
- Advice on the design and conduct of clinical trials
- Protocol review and statistical methods sections
- Sample size calculations and statistical analysis plans
- CRF design: e-trial facility or in printable format
- Preparation of randomisation schedules
Data Management
- Data capture and document management
- Database management, validation and querying
- Data management plan and data dictionary
- Coding of drugs and events (WHO and MedDRA)
- Serious Adverse Event reconciliation
- Incorporation of electronic laboratory data
- Study metrics reporting
- Management of study closedown phase
Quality Assurance
- SOPs incorporate all regulatory and legal requirements
- ISO 9001: 2000 quality management system
- TickIT for software development
Randomisation Services
- IVRS (Interactive Voice Response System) and web equivalent
- Demonstration systems for use in training
Security
- Firewall protection and extensive data security systems
- Provision of IVRS and Web service 24/7
Web Portal Facilitating E-trials
- Electronic data capture, query resolution and secure information dissemination
- Metrics reporting and facilitation of study monitoring
- IDMC reports dissemination
- Access to safety data
- Drug supply management
Other Services
- Health Economics
- Coordination of the work of endpoint adjudication committees
- Training courses