Phase I/II project management and clinical strategy

Our project management team is experienced in early-phase clinical trial planning and management. We ensure efficient coordination and monitoring of clinical trials based on an integrated approach. Our teams  implement plans through to proof-of-concept/phase II, including:

  • investigator and clinical research unit identification, qualification, and selection;
  • study protocol writing and review;
  • case report form design;
  • coordination of clinical trial applications;
  • budgeting and budget management;
  • risk management;
  • study oversight;
  • supervision, coordination and follow-up of SAEs during study conduct;
  • coordination with data management teams, bioanalytical laboratories and other partners; and
  • clinical study report writing and review.