Services include but are not limited to

  • Early-phase strategic planning
  • Assessment of pre-clinical programs
  • Introduction to Key Opinion Leaders
  • Identification of appropriate clinical trial sites
  • Trial design and development
  • Preparation of Ethics Committee submission packages
  • Submissions to Regulatory Bodies
  • Organization of Investigators’ Meetings
  • Overall project management
  • Site management and quality assurance
  • Bio-statistical support
  • Medical report writing
  • Clinical events adjudication
  • Medical management and monitoring
  • Data and safety monitoring board coordination
  • Import of investigational drugs and devices
  • Compliance with local legislative requirements
  • Local Sponsor activities for clinical trials and regulatory approval on behalf of foreign corporations
  • Drug and device regulatory approval, reimbursement and realization
  • Sales and distribution of high end pharmaceuticals and medical devices