Research support

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:

Biostatistics

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
  • Reporting to regulatory standards
  • IDMC reporting
  • Participation in study committees
  • Attendance at regulatory meetings
  • Remote statistical monitoring
  • Publication and presentation of study results
  • Statistical advisory consultation service
  • Statistical training courses

Study Design

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
  • Contribution to grant proposals
  • Protocol review and statistical methods sections
  • Sample size calculations and statistical analysis plans
  • CRF design: e-trial facility or in printable format (eCRF/CRF)
  • Preparation of randomisation schedules

Data Management

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
  • Document management including Data Management Plan and data dictionary
  • Clinical Coding of medications and events (WHO and MedDRA)
  • Serious Adverse Event reconciliation
  • Study metrics reporting
  • Management of study closedown phase

Quality Assurance

  • SOPs incorporate all regulatory and legal requirements
  • ISO 9001: 2015 Quality Management System
  • ISO 27001: 2013 Information Security Management System

Randomisation Services

  • Randomisation Schedules
  • IVRS (Interactive Voice Response Systems) and web-based interfaces, 24/7
  • Emergency unblinding facility
  • 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
  • Documentation repository
  • Pharmacovigilance
  • Drug supply management
  • Endpoint Adjudication
  • ePROMs
  • Full audit trail functionality
  • Training and ongoing support

Other Services

  • Project Management
  • Record Linkage
  • Endpoint adjudication support
  • Safety Reporting administration
  • Analytical Platform provision
  • ECG Core Lab for standardised ECG interpretation and review