Centre for Biostatistics and Clinical Trials (BaCT)

What is BaCT?

Based at Peter Mac for over 40 years, the Centre for Biostatistics and Clinical Trials (BaCT) provides a full range of services to clinical trials to facilitate the advancement of patient treatments and improved outcomes for cancer patients.

BaCT supports diverse clinical trials:

  • Investigator-initiated studies
  • Company sponsored trials
  • Collaborative group studies

Why collaborate with BaCT?

  • 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 co ordination of oncology clinical research
  • Support for grant applications

Services

Study Design & Development

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

Data Management

  • eCRF design and development (21CFR Part11 compliant)
  • Integrated Web Response Systems (IWRS)
  • 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
  • including master, site-specific 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
  • Source data verification
  • Protocol amendments
  • Risk management
  • Site management
  • Vendor management
  • Safety reporting management
  • Trial management committees

Commitment to research

With a legacy of reinvention in an ever-evolving clinical trial landscape, BaCT have 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 and 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, not-for-profit and commercial organisations.

Contact details

Ms Alison Hall

Phone: 03 8559 7520

Email: [email protected]