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