Project management

Smooth Drug Development is proud of its team of Project Managers.
Project management begins at a very early stage – at the time of receipt of a Request for proposal for a new study. Upon receipt of such a request the Head of clinical and regulatory operations department identifies potential Project manager based on his/her experience and core competencies.
During the RFP process the Project manager is actively involved in:
  • Clinical study feasibility
  • Review of clinical trial documents
  • Pre-planning of a study
  • Preliminary site selection
  • Process of the study budget preparation
  • Preliminary risk assessment and mitigation plan
The result of this work is a Proposal for conduct of a study, which is sent to the Sponsor for assessment and participation in the selection process.
Project management of a study is performed according to the Project management plan that contains all the information about the project, involved parties, used parts of the Quality management system, milestones, risks and other significant aspects of the study.
During the study, the project manager:
  • Serves as the main contact person for the study Sponsor
  • Coordinates the project team and service providers
  • Prepares study guidelines and tracking tools
  • Manages the process of regulatory submissions
  • Conducts training of the project team
  • Controls achievements of project milestones
  • Controls execution of the project budget
  • Provides progress reports to the Sponsor
  • Regularly assesses the risks and takes corrective actions
Completion of the project is the delivery of Trial Master File to the Sponsor and obtaining the final Satisfaction questionnaire assessing our work on the project.