Centre for Biostatistics and Clinical Trials

Based with us for over 40 years, the Centre for Biostatistics and Clinical Trials (BaCT) provides a full range of services to support Investigator Initiated Clinical Trials to facilitate the advancement of patient treatments and improved outcomes for cancer patients

Why collaborate with Centre for Biostatistics and Clinical Trials

There are many reasons to collaborate with  BaCT, these include: 

  • Established relationships with major oncology units across Australia and New Zealand 
  • Collaboration throughout all phases of clinical trial 
  • Efficient and low-cost data capture strategies 
  • Clinical trial and data management for optimization of protocol delivery 
  • Promotes and fosters optimal integrity and highest quality across clinical trial initiatives 
  • Extensive experience with collaborative groups 
  • National leaders in the coordination of oncology clinical research 
  • Services 

Study Design and Development 

  • Expert advice on trial design from clinical, operational and statistical perspectives 
  • Collaborative protocol preparation 
  • Advice regarding all areas of study conduct 
  • Customised services for biostatistical and clinical trial needs 

Database Development & Data Management 

  • eCRF design and development (21CFR Part11 compliant) 
  • Trained and experienced data management team  
  • Source data verification  
  • Consistency checks and data validation 
  • Data processing 
  • Medical coding 
  • User training 

Study Start-Up 

  • Site preparations and initiation 
  • Trial Master File (TMF) preparation & management 
  • Protocol specific training 
  • Essential document preparation 
  • Master Patient Informed Consent Forms

Statistics 

  • Study design and protocol development 
  • Interim and final statistical analyses including advanced statistical modelling 
  • Development of statistical analysis plan (SAP) 
  • Safety review committees statistical reporting 
  • Randomisation and treatment allocation including restricted and adaptive methods 
  • Sample size and power calculations 
  • Assistance with manuscripts 

Clinical Trial Management 

  • Study progress reporting 
  • Protocol amendments 
  • Risk management 
  • Site management 
  • Vendor management 
  • Safety reporting management 
  • Trial management committees 

Centre for Biostatistics and Clinical Trials commitment to research 

With a legacy of reinvention in an ever-evolving clinical trial landscape, BaCT has implemented e-technologies to provide a comprehensive and adaptable service in the management and conduct of clinical trials. 

BaCT has extensive expertise in the facilitation of:  

  • Oncology clinical trials 
  • Specialist diagnostic trials 
  • Translational research 
  • Retrospective studies 
  • Treatment-based studies 

The team implements high-quality biostatistics, clinical, data management, and trial centre project management services to a diverse research community. BaCT’s research collaborators include clinician-researchers, translational researchers, cooperative oncology groups and not-for-profit organisations.

Centre for Biostatistics and Clinical Trials contact details 

Ms Jacqui Cumming 

  • Phone: (03) 8559 7521 
  • Email: This email address is being protected from spambots. You need JavaScript enabled to view it. 

Related links

CTIQ