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Working Hours

Monday - Friday 09:00AM-17:00PM
Saturday - Sunday CLOSED

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Services

clinical

Clinical

  • Project feasibility
  • Study start up
  • Protocol and IB development
  • Monitoring
  • Site management
  • Clinical trial coordination
  • Project management
  • Site close out
Patient-recruitment

Patient recruitment

  • Patient identification (due diligence)
  • Patient recruitment and retention
  • Comprehensive prescreening
  • Phone appointment system
  • Study site training
  • Money back guarantee
Quality-Management

Quality Management

  • Investigator site audits
  • Quality system management
  • Vendor audits:
    • Good clinical laboratory practice (GCLP)
    • IP distribution and storage facilities
    • Central laboratories
    • Archive facilities
    • Bio-repositories
    • Bio-analytical laboratories
  • GLP and GCP audits
  • SOP development
  • Computerised system audits (CTMS, eTMF and EDC)
Data-Management

Data Management and Statistics

Biostats

  • Input into protocol design
  • Sample size calculations
  • Development of statistical analysis plans
  • Programming of tables, listings and figures
  • Statistical analysis (interim and final)
  • Publishing of statistical reports
  • General statistical advice on efficacy and patient safety

Data Management

  • CRF design and development
  • Edit check programming
  • Data cleaning and validation
  • Laboratory and third party data integration and reconciliation
  • Medical coding
  • Provision of CDISC compliant SDTM and ADaM datasets
  • ePatient report outcomes (ePRO)
  • End point adjudication
  • Risk based monitoring (RBM)
Medical-writing

Medical writing

  • Medical writing
  • Medical writing of protocols, IB and CSRs to ICH-GCP standards
  • Endpoint development and evaluation
  • Input into pharmacokinetic and pharmacodynamic considerations
  • Statistical analysis and interpretation
  • Review and reporting of safety information
  • Promotional material review
Regulatory

Regulatory

  • Regulatory strategy development:
    • Regulatory due diligence and gap analysis
    • Dossier evaluation
    • Competitive intelligence
    • Pre-submission and resubmission meetings
    • Bioequivalence and clinical strategies
  • Submissions for: new chemical entities, new biological medicines, generics, biosimilars, OTC and medical devices

Australian R&D Tax Incentive when Conducting Research in Australia

The Research and development (R&D) tax incentive encourages companies to engage in R&D benefiting Australia, by providing a tax offset for eligible R&D activities.

The R&D tax incentive replaced the R&D tax concession from 1 July 2011 and applies differently from the concession.

In principal, the tax incentive has been developed to promote R&D in the industry that otherwise may not have been conducted. The incentive allows for more predictability which allows for small and mid-sized companies to engage easier in R&D in Australia.

Complete Phase Consulting can provide you with a local R&D tax expert who can discuss the requirements to qualify for these incentives and help you every step of the way.