D5tsspo2qxy5epyunxmk cns

Clinical Network Services

Toowong, Queensland, AU

CNS creates value for small-medium sized biotechnology companies by progressing early stage products through phase 1 & 2 clinical trials or the marketplace sooner.

CNS offers a unique service where it integrates BioDesk, an intelligent global product development and regulatory affairs consultancy, with our committed, highly experienced Australian/New Zealand clinical operations and biometrics teams. BioDesk’s expert consultants offer chemistry, manufacturing and control (CMC), toxicology, clinical and regulatory affairs strategic advice and guide products efficiently through critical post-discovery development and into the clinic for the first time.

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Quality Assurance
Price on request

CNS is committed to quality and integrity in all aspects of our work and services. The Quality Assurance (QA) Department is independent to other functions at CNS and the Director of QA reports to the CNS Executives.

CNS' QA division is led by Susan Jones. Having worked in Europe, North America and Australasia in both... Show more »

CNS is committed to quality and integrity in all aspects of our work and services. The Quality Assurance (QA) Department is independent to other functions at CNS and the Director of QA reports to the CNS Executives.

CNS' QA division is led by Susan Jones. Having worked in Europe, North America and Australasia in both clinical operations and quality roles, Susan brings more than 20 years of GCP experience and a practical approach to quality. As Director of QA, Susan manages the quality team and develops solutions in response to clients’ needs.

CNS' QA offer clients the following services:

  • Individual consultations
  • Development/review of a Quality System
  • Creating/reviewing SOPs
  • Review of current practices including ethics committees, governance offices, and research groups
  • Assessing adherence to procedures and policies
  • Development of annual audit plans including implementation if required
  • Pre-audit preparation and training
  • GCP training
  • GCP audits, including:
    • Investigational study site
    • Trial Master File
    • Vendors/facilities
    • IT
    • Medical Writing
    • Biometrics
    • Systems
    • Laboratories
  • GLP audits of toxicology and bioanalytical facilities
  • GMP audits of local and international manufacturing facilities

CNS welcomes pre-award/vendor selection audits and on-study audits from clients, contractors and regulators.

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Medical Writing
Price on request

CNS understands the importance of bringing experts together in designing clinical trials. We have taken this a step further by resourcing our broad medical writing team within our BioDesk division.

BioDesk's medical, toxicology, CMC and regulatory experts work closely with the senior clinical operations team in the... Show more »

CNS understands the importance of bringing experts together in designing clinical trials. We have taken this a step further by resourcing our broad medical writing team within our BioDesk division.

BioDesk's medical, toxicology, CMC and regulatory experts work closely with the senior clinical operations team in the development of the following core documents:

  • Preclinical Program Gap Analysis
  • Drug Development Plan (DDP)
    • DDPs are designed in close partnership with our clients and are global in scope, meeting the international standards of the EMA, FDA, ICH and the World Health Organisation (WHO)
  • Protocol Development
    • Full protocols are written with input from CNS' medical, biostatistic & clinical experts ensuring practicality, compliance and quality
  • Investigator Brochure (IB)
    • IBs are written with input from CNS’ medical, toxicology and CMC experts and in accordance with quality practices
  • Independent Toxicology Report (ITR)
    • ITRs are generated by our toxicology experts
  • ECTD ready Clinical Study Report (CSR)
    • CSRs are written with input from CNS’ clinical and quality assurance experts and the Local Medical Monitor, in accordance with protocol requirements and ICH E3 standards
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Biostatistics
Price on request

CNS' Biostatistical team's core activities are to provide biostatistical and pharmacokinetic/pharmacodynamic analysis and data presentation services to the pharmaceutical/biotech industry and government/academic organisations, with a primary focus on data generated from clinical trials.

*These services include... Show more »

CNS' Biostatistical team's core activities are to provide biostatistical and pharmacokinetic/pharmacodynamic analysis and data presentation services to the pharmaceutical/biotech industry and government/academic organisations, with a primary focus on data generated from clinical trials.

These services include undertaking:

  • Study design and sample size/power calculations
  • Statistical analysis plan (SAP) and protocol writing
  • Randomisation procedures
  • Table, figure and listing presentations for documents to be submitted to regulatory authorities
  • Standard hypothesis testing i.e. comparison of groups
  • Statistical data modelling (e.g. regression, general linear modelling, non-linear modelling, mixed-effects modelling, survival analysis, etc.)
  • Pharmacokinetic/pharmacodynamic analysis including non-compartmental analysis (NCA) and population non-linear mixed effects modelling and simulation
  • Optimal design of experiments
  • Clinical trial simulation
  • Data review and quality assurance
  • Data summaries, reports and publications
  • Interpretation and communication of results to non-statistical audiences

All analyses are undertaken with programmed reproducible methods using industry standard software packages including SAS, R, WinNonlin and NONMEM. All work is undertaken and stored in a secure, dependable and fully backed-up computing environment and in accordance with our own SOP’s and work instruction documents.

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Data Management
Price on request

In 2013, CNS launched its Biometrics department, a hugely successful expansion of CNS' in-house services, achieving improved speed, quality and integration of program management for all of our clients programs. CNS offer a strong and experienced Biometrics team providing an optimised customer centric service making use of a... Show more »

In 2013, CNS launched its Biometrics department, a hugely successful expansion of CNS' in-house services, achieving improved speed, quality and integration of program management for all of our clients programs. CNS offer a strong and experienced Biometrics team providing an optimised customer centric service making use of a globally recognised suite of electronic data capture solutions and data analysis tools.

CNS’ service model is to offer the best in market EDC solution, yet retain our flexibility so as to allow CNS to cater for specific Client EDC preferences. CNS’ preferred EDC systems are Merge and RAVE both of which are provided as Software as a Service (SAAS) solution by eClinical OS and Medidata respectively. CNS standardly offers our clients both platforms to ensure a best fit for our clients short and long term planning. CNS Biometrics software partners are considered best in market with respect to profile, user driven EDC functionality, Support (helpdesk), Technology, Compliance with 21CFRpart11, Costs, and Integration capabilities with other clinical IT solutions.

CNS' Data Management services include:

  • Fully web enabled eCRF & clinical DB (IT validated, 21CFR11 compliant, secure, 24x7)
  • Data capture & validation (with full audit trail)
  • Listings for Safety Monitoring Committee (SMC) meetings
  • Automated randomisation solutions
  • Electronic diary cards
  • Clinical product inventory systems
  • Coding of medical terms including:
    • Serious Adverse Events (SAEs) & medical history using MedDRA
    • Medication using WHO-Drug Dictionary (WHO-DD)
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Clinical Project Management
Price on request

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... Show more »

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
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Project Management, Consulting, & Support Services
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Data Services
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Clinical Research
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Computational Modeling
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Biostatistics & Bioinformatics
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Marketing, Communication & Graphic Design Services
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Editorial and Writing Services
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Clinical Trials, Consulting, and Management
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Product Quality Control
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Product Development, Testing, and Packaging
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