QIMR Berghofer Clinical Trials & Biostatistics Unit

banner

The QIMR Berghofer Medical Research Institute (QIMR) has a long-standing international reputation in terms of conducting translational clinical studies, including early and late phase clinical trials. The Institute’s Clinical Trials and Biostatistics Unit (CTBU) was recently established by Professor Sanjoy Paul, following relocation of his research group from the Queensland Clinical Trials & Biostatistics Centre (QCTBC) at The University of Queensland (20092013). With a wealth of highly trained personnel, regulatory strength and the state-of-art infrastructure, CTBU has been actively involved in the design and conduct of a number of national and international clinical trials in different therapeutic areas.

The CTBU of QIMR Berghofer provides expertise and infrastructure to design, conduct, and facilitate high quality clinical trials, non-trial clinical studies, and biostatistical research, across a broad range of disciplines. Current therapeutic areas include metabolic and autoimmune diseases, critical care, blood cancer, and geriatric medicine. CTBU also provides high quality research consulting services to clinical researchers and bio-pharmaceutical companies. All professionals of the Unit are GCP-trained, and conduct clinical studies strictly following the regulatory requirements and pharmaceutical industry standard. CTBU has active collaborations with several international academic institutes and pharmaceutical companies, including Imperial College London, University of Oxford, Peking University, Bristol Myers Squibb and Novo Nordisk.

Accreditation

GCP trained staff and participation in GCP clinical trials.

Year of Establishment

2009 (moved to QIMR Berghofer in 2013)

Pricing and Access

For pricing information on the services below, please contact Prof. Sanjoy Paul at sanjoy.paul@qimrberghofer.edu.au or +61 (0)7 3845 3020.
Further information on the CTBU can be found on its website: www.qimrberghofer.edu.au/ctbu


KEY TECHNOLOGY

SERVICES

Study design

 

  •  Identification & choice of multiple primary and secondary study outcomes
  • Basis and justification for the number and time-window of study visits
  • Comparative power analyses for the primary outcome(s) with extensive simulation results

  • Approach to adverse event reporting
  • Statistical analysis approaches
  • Development of study protocol

 

Database Development and Management

CTBU promotes the use of regulatory approved electronic data capture (EDC) systems for all clinical studies that conform to GCP and regulatory guidelines such as 21 CFR Part 11, and which are built on modern architecture, using leading standards. Key aspects of the database development include:

  • Development of electronic case report form (eCRF)
  • Development of a robust clinical database, on OpenClinica® platform
  • Validation of database and development of associated standard operating procedures (SOPs)
  • Training of project research staff, including provision of appropriate manuals and web-hosting of database 
  • Randomisation services
  • Management and continuous monitoring of database
  • Quality analysis and quality control
 

Biostatistical Consulting

 
  • Development of study design and comparative power analysis
  • Development of statistical analysis plans for interim and main analyses of the studies
  • Development of charter for Data and Safety Monitoring Boards (DSMB), and provision of analysis and reporting for the DSMB
  • Statistical analyses
  • Specialised analyses for safety reporting
  • Statistical and clinical reporting
  • Active participation in manuscript writing