Services

We are experienced in the conduct of successful, safe, and on-budget delivery of clinical trials including the implementation of clinical trial protocols, data management, grant applications, and ethics submissions. 

Mature woman with shoulder-length grey hair and glasses is pointing at a computer screen. Either side of her sit two younger team members - a man with brown hair and a beard, wearing glasses and a woman with long, brown curly hair.

We provide central coordination for multi-site trials, as well as site-specific support from study initiation through to study closure, including safety and data monitoring. We work with the protocol investigator team to operationalise the trials and we work with sites on the development and improvement of participant recruitment strategies.

We also provide education and training, biostatistical and health economics expertise, and an array of data management services including case report form development, database setup, data collection, and data entry support. Using a risk-based program we conduct monitoring to ensure rigorous reliable trial data capture within the principles of Good Clinical Practice.

Our skilled writers help you to develop clinical trial protocols, generate literature reviews as well as prepare grant applications and ethics submissions.

We have a strong track record of supporting investigator-initiated clinical trials. We also welcome collaborations with industry.

Contact us to discuss your study idea.

New study design and development

  • protocol development
  • methodological expertise and input
  • trial design experts
  • patient-reported experience measures (PREMS) and patient-reported outcome measures (PROMS) input
  • sample size calculations 
  • systematic reviews
  • literature reviews

Multi-site clinical trial coordination

  • project management/trial coordination
  • clinical trial sponsorship (via UTS)
  • Human Research Ethics Committee Review (HREC) submissions and approvals 
  • indemnity and clinical trial insurance
  • Site Specific Approvals (SSA)
  • Clinical Trial Notifications (CTN/X with the TGA)
  • Standard Operating Procedures (SOPs), guidance and templates
  • trial registration 
  • clinical trial research agreements
  • site feasibility and confirmation
  • patient information and consent form development 
  • assessment tool licensing

Data management

  • randomisation schedule development
  • during trial randomisation services
  • case report form (CRF) build for direct data entry (REDCap)
  • development of data collection worksheets
  • database access and helpdesk
  • data management plans
  • monitoring plans 
  • monitoring performance (trial and pharmacy)
  • statistical analysis plan
  • statistical analysis
  • health economic analysis 

Safety reporting

  • adverse event/serious adverse reporting
  • medical monitors
  • Data and Safety Monitoring Committee secretariat 

Manuals

We provide:

  • Coordinating Principal Investigator Manual
  • Principal Investigator Manual
  • E-consent Manual

 
We help you develop:

  • Site Investigator Manual 
  • Pharmacy Manual 
  • randomisation schedules
  • online randomisation and unblinding
  • pharmacy monitoring 
  • unblinding services

Investigational medical product

  • GMP-certified manufacture (outsourced)
  • stock ordering 

Project management

  • budgets
  • study payments and tracking 

Site research staff training

  • site initiation
  • consent training
  • Good Clinical Practice (GCP) training 

Recruitment

  • printed promotional materials including posters, postcards and brochures
  • website and social media
  • consent scripting

Writing and editing

  • clinical trial protocols
  • literature reviews
  • grant applications
  • ethics submissions
Acknowledgement of Country

UTS acknowledges the Gadigal people of the Eora Nation, the Boorooberongal people of the Dharug Nation, the Bidiagal people and the Gamaygal people, upon whose ancestral lands our university stands. We would also like to pay respect to the Elders both past and present, acknowledging them as the traditional custodians of knowledge for these lands.