PROJECT MANAGEMENT

Our project management team serves as the Sponsor liaison and works to create the best suited team for each clinical study. Our project managers are extremely customer focused and directly accountable to Sponsor for all project-related responsibilities.

Our project managers will maintain a close follow-up with internal departments and communicate the sponsor transparently on project updates at all stages of project execution. Our key communication steps includes:

  • Prior to project execution: communications regarding ethics committee approval details, MoH submission and approval details, project timelines, planned project dates, investigational products details, etc.
  • During the project execution: period wise study details such as number of volunteers planned, entered and completed the study, confirmation of dosing in all periods, acknowledgement of study monitoring report from monitor / sponsor, start and end dates of bioanalysis, start and end dates of statistical analysis, etc.
  • After the project execution: submission of preliminary results / report, submission of final report / integrated report, etc.

Our expertise includes:

  • Project managers with hands-on experience,
  • Single point of contact for accountability
  • Therapeutic area experts
  • Trained on GCP
  • Global regulatory experience
  • Predefined Risk Mitigation strategies
  • Successful Track record of completing trials on time and within budget.