Core Clinical Trial Services

CNS understands that the small–medium international biotech/biopharm industry business model requires a leaner, more results-driven paradigm for implementation, management and reporting of early phase clinical trials. In keeping with our philosophy of not being limited by traditional CRO templates, the CNS project manager will lead an experienced clinical team that meets industry expectation by delivering a focussed and pragmatic suite of services.

To this end, CNS offers the following core clinical services either as stand-alone components or as a full integrated solution:

Overall Project Management
Site Management and Monitoring
Trial Master File/Regulatory Binder Maintenance
CRF Design and Data Management including EDC Solutions
Data Safety Monitoring Board/Committee Co-ordination
SAE Collation and Reporting including Local Medical Monitoring
Biostatistical Analysis including PK/PD Parameter Analysis
Clinical Study Report Writing
Study/Site Audits
In Country Sponsorship/Local Legal Entity.

Clinical Design & Consultancy

Throughout the process of designing, setting up and running a clinical trial, CNS provides a trusted, quality service using its expertise in planning, monitoring, reviewing and reporting of clinical trials.

CNS works collaboratively with our clients to ensure Australia is the best place for their trials by leveraging off our relationships with phase I units, SMOs and therapeutic specialists/clinicians. CNS then combines this strategy with our extensive early phase experience to develop protocol(s) and programs that deliver the best possible solution(s) to our clients, allowing them to meet their business goals such as market driven timelines, investor needs and regulatory expectations.

Implementation of agreed strategies will be overseen by experienced CNS project managers leading a team of internal and external specialists including medical writing, regulatory, toxicology and clinicians with relevant therapeutic expertise.

Typical areas where CNS assists our clients in trial planning and design are:

Site/recruitment feasibility
Protocol design and development
Investigator Brochure (IB) writing
CRF design & printing
Independent Toxicological review
Australasian trial sponsorship where international clients do not have a local subsidiary or partner
Advice on importation/customs and assistance with shipping strategies
Clinical Trial Insurance.

Furthermore, CNS can also support these services at an international level through our strategic partners based in the USA, Europe and New Zealand.