We provide a range of free support services to clinical researchers conducting research under the auspices of Glasgow Biomedicine.
We offer 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:
Our biostatistics advisory service has an emphasis on contributing to the development of collaborative funding applications, statistics courses (basic and advanced), and serious adverse event and pharmacovigilance reporting infrastructure for clinical trials.
- Statistical analysis and reporting to regulatory standards
- Participation in study committees and regulatory meetings
- Publication and presentation of study results
- Statistical advisory consultation service
We provide a telephone (IVRS) and web-based randomisation infrastructure for enrolling/randomising patients into randomised clinical trials.
Study-specific provision, including telephone charges, voice recordings and production, setup and administration of individual randomisation schedules will, however, be met by the individual study budgets.
- 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
We use novel electronic tools to enhance the conduct of clinical research, particularly related to the use of routinely collected health data.
- 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
- SOPs incorporate all regulatory and legal requirements
- ISO 9001: 2015 Quality Management System
- ISO 27001: 2013 Information Security Management System
- IVRS (Interactive Voice Response System) and web equivalent
- Demonstration systems for use in training
- 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
- Coordination of the work of endpoint adjudication committees
- Continuing professional development courses