PROTOCOL DEVELOPMENT

Each project is implemented in line with an approved Study Protocol developed by the Facility and approved by the sponsor. We ensure that the protocol is coherent with scientific requirements of study and complies with GLP principles where possible. The Study Protocol includes details of the study/experimental procedure, individuals involved in the project and the locations where the project will take place.

Our sample protocol outline:

  • Background
  • Aims and objective
  • Description of test item
  • Detailed methods and materials
  • Ethical considerations
  • Statistical analysis
  • Efficacy criteria
  • Key study Personnel
  • List of SOPs to be used.

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