Clinical Trial Management


To pull all critical elements of a clinical trial together to ensure its successful delivery on time, within budget and to a high standard:

  • Conduction of feasibility assessments and development of pilot studies
  • Sample size Plan design management and execution (timelines and projections)
  • Clinical trial coordination, including sample management, with storage requirements
  • Arrangements for treatment allocation and labelling & distribution of trial drugs
  • Launch meeting organization & conduct initiations of participating sites
  • Research Team support training and schedule participant visits and follow-up, ensuring high quality of data collection
  • Newsletters development & trial promotion to the Research Teams
  • Maintaining study site files in accordance with GCP requirements
  • Regulatory support
  • Safety reporting - manage pharmacovigilance activities in accordance with regulations
  • Financial and resources managementConduction of additional exploratory analyses
  • Review or writing of the clinical study reports
  • Assistance with sites training
  • Clinical trial monitoring - conduct central and on-site monitoring
  • On-going oversight & advice to participating sites
  • Help identify & address barriers to timely recruitment and conduct
  • Elaboration of reports for funders, regulators, sponsors
  • Facilitation of audits & regulatory inspections
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