Clinical Program Management

CNS' clinical Project Management (PM) team are considered experts in initiating and managing phase 1 and 2 studies. The expertise and high level of customer service delivered by our PMs has seen a number of clients continue to engage CNS for their phase 3 trials. CNS' clinical team members have an average of ~10 years industry experience per member making CNS one of the most experienced clinical teams in Australasia.

CNS' Clinical Operations is managed and lead by our team of Project Managers, with a team of Clinical Research Associates (CRAs) located Australia and New Zealand wide. Each of our CRA's have significant expertise in Australia/NZ clinical regulations, and managing studies at each of the regional phase I units as well as working with hundreds of private and public hospital based clinicians across Australia and New Zealand.

CNS is committed to the ongoing development of our staff through SOP, GCP and company training, as well as external courses/seminars. Our commitment to CNS staff training ensures that clients have quality resources assigned to their projects.

Our Project Managers (PMs) have extensive experience working with international SME biotechnology clients and therefore understand the importance of timelines and budget management whilst maintaining  quality standards that are meaningful to international regulators and investors alike.

Our differentiated clinical expertise includes:

  • Extensive and long lasting relationships with phase 1 units
  • In country sponsorship/local legal entity establishment
    • Relevant if there is no Australian/New Zealand company affiliate
    • Local presence in Australia enables access to R&D tax credit
  • Clinical trial management
    • Highly experienced project management, supported by our biomedical and scientific experts within the BioDesk team
    • Expert review of all core documents from protocol to CSR
    • Intelligent study design and protocol writing
    • Adept site selection, management and monitoring
    • Strong relationships with local vendors (laboratories & IP storage and distribution)
    • High level regulatory compliance management including trial master & site file
  • Safety Management
    • A deep understanding of requirements for the Safety Monitoring Committee role in cohort review/
      study continuation decisions, SAE collation and reporting including local medical monitoring
    • Expert local and international medical monitoring and consulting through our own in-house and external medically licence

Our full scope of clinical program services includes:

  • Full study project management – regional and international
  • Protocol development/writing
  • Site identification and selection
  • Investigator Brochure (IB) writing
  • Study implementation including ethics and regulatory coordination
  • Investigator Meeting coordination
  • eCRF design and implementation
  • Full data management
  • Biostatistics (including PK/PD analysis and modelling)
  • Site management/monitoring
  • Bioanalytical laboratory analysis & reporting
  • Australian & New Zealand entity & sponsorship
  • Serious Adverse Event (SAE) reporting and Local Medical Monitoring (LMM)
  • Clinical Study Report (CSR) writing