The Clinical Operations function of a company is key to the delivery of clinical trials

Without our team at Agile global clinical research activity could not be delivered. Our Clinical operations teams are responsible for designing, planning and physically running Phase I – IV clinical trials within the drug discovery industry. Depending on the size and type of clinical trial being conducted, clinical operations teams can be either small regional teams or large international groups of people. Our services include.

  • Administrative roles or clinical trial administrators who support the day to day activities for the trial
  • Field-based monitors or clinical research associates who travel to different research units to ensure the trial is running correctly
  • Clinical study/project managers who manage the teams or running of the trial (usually on a region or global level)
  • Directorship roles where the person will have the sole responsibility for a trial
  • Our Teams have a lot of interaction with people in a range of other departments including clinical science, clinical quality assurance, data management, biostatistics and regulatory affairs to ensure that the data and information needed by these other departments is delivered so they can decide if a trial has been successful
  • Development of protocol and other study documents
  • Identification of clinical trial sites and investigators
  • Training, startup, and management of clinical sites
  • Managing logistics of study materials.
  • Providing a channel of communication between research teams specializing in clinical science, statistics, pharmacovigilance, data science, regulatory activities, legal, and marketing, while keeping them up to date and on task.
  • Fiscal management
  • Identifying project risks and planning for changes ahead of time
  • Internal and external stakeholder management.
  • Quality management
  • Trial closeout and reporting