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Clinical trial documentation

Clinical Development

Strategic Clinical Development To Simplify And Accelerate Product Development

We have a unique group of people with the right experience, knowledge, contacts and focus to guide you through the increasingly complex clinical development maze. Via our clinical development team, we work in partnership with our clients utilising a strategic and customised approach, to deliver successful clinical trial development programs in a cost and time efficient manner.

The clinical development team works in close concert with our regulatory services, medical services and market access teams to seamlessly converge and integrate clinical (medical) and commercialisation pathways. This optimises resources, processes and product development timelines, while reducing risks, leading to improved product development and market access outcomes.

We see your needs and help you with:

Clinical Strategy

  • early phase product development roadmaps
  • clinical study design (inclusion/exclusion criteria, comparators, endpoints, clinical trial size, etc)
  • study specific project management and monitoring plans (including risk management)
  • stakeholder interaction and management (regulators, physicians, etc)
  • key opinion leader panels and advisory boards
  • troubleshooting to keep development programs moving forward

Clinical Research

  • Q of L – studies / surveys / assessment measures / outcomes research
  • clinical trial site identification and qualification including feasibility assessments
  • clinical trial site training and support
  • clinical trial protocol development (concept to final)
  • clinical trial investigator’s brochure
  • clinical trial study set-up (regulatory and ethics submissions)
  • clinical trial investigator meetings / study start-up meetings
  • clinical trial master files
  • study amendments
  • medical monitoring
  • patient recruitment and retention plans

The spiralling cost of life-science product development and increasing complexity of clinical trials means there is an urgent need to optimise efficiencies and minimise risk in clinical development.

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