Core Capabilities

We operate primarily in Australia and New Zealand.

We work on global or local projects.

Our core resource capabilities include Project Director/Project Managers, Clinical Research Associates and Clinical Trial Administrators.

In addition, we have biostatistical capabilities and alliances with various data management vendors.

All of our work is undertaken utilizing either our own suite of Standard Operating Procedures or those of our clients.

Our team is trained in Good Clinical Practice Principles and we work according to global regulatory standards (including projects under IND/Food and Drug Administration (FDA) expectations).

Our core capabilities include:

  • Clinical Trial Network Affiliation: a unique aspect of our business that allows us to keep the capabilities databases, assist with feasibility and co-bid for projects with our neuroscience trial networks in cognition/dementia (AC4R), multiple sclerosis (MS Research Australia), stroke (Australasian Stroke Trials Network), epilepsy (Australia New Zealand Clinical Trials Network) and movement disorders (Movement Disorders Society of Australia Clinical Research and Trials Network)
  • Imaging studies expertise: the majority of our studies involve imaging (MRI, CT, PET) and thus we are well versed in the unique requirements of such studies including the technological aspects and essential site capabilities required
  • Biomarkers and Bio banking: the majority of our studies involve these requirements and thus the same applies here
  • Study design: protocol (and associated documents) and Investigator brochure preparation or finalization
  • Start-up activities: site selection and feasibility, preparation and submission of Institutional Review Board/Ethics applications, Investigator meetings, contract negotiation
  • Site Initiation, monitoring, site management and close-out activities
  • Investigator meeting organization, participation and management
  • Third party vendor selection and management
  • Project Management
  • Study budget negotiation (sites and vendors) as well as budget management
  • Data management expertise with internal and external vendor capabilities
  • Biostatistician who is a specialist in neuroscience projects
  • Medical Monitoring capabilities; utilizing only neurologists for this service as required
  • Data Safety Management Board selection, preparation of associated documentation, maintenance and assistance in report preparation
  • Regulatory: assistance in preparation of IND packages, attendance at pre-IND, End of Phase 2 meetings, pre-NDA meetings
  • Medical writing including Clinical Study Report preparation
  • Preparation of Standard Operating Procedures
  • Training of site and study personnel in Good Clinical Practice.