Home      About Us       Management      Services     Clients      Contact Us 
Project Management &
           Protocol Development
Clinical Monitoring
Data Management & EDC
Programming
Statistics
Medical Writing
Medical & Safety Monitoring
Quality Assurance
Project Management Protocal
 


Strong project management is key to the success of a project.  One thing that distinguishes us from other larger CROs is that we have very tightly integrated team that communicates very effectively. A project manager serving as a single point of contact is assigned to each project for a Sponsor. Clinesian’s project managers have a breathe of drug development experience (minimum of 12 years) managing all aspects of clinical trial operations.  Clinesian’s project managers work very closely with the Sponsor to ensure that a timely and quality product is delivered. The project manager oversees a cross-functional team such that the entire clinical trial process is controlled and integrated from the initiation of the research sites to the delivery of the final clinical summary reports. For example, starting with development of the protocol itself, statisticians, programmers and data managers are included in the review cycle to insure that the appropriate data are captured and the analysis is carried out as specified.   This integrated team is comprised of individuals who take ownership of their assigned responsibilities and a leader, the project manager, who coordinates their efforts and is the liaison between the team and the client. This effectively led coordinated proactive team ensures that key milestones and project time lines are consistently met.

Our project management services include the following:

  • Project management
  • Protocol design and development
  • Study Planning, Timelines, and Implementation
  • Study Metrics
  • Financials including budget preparation, negotiation and tracking
  • SOPs, GCP compliance,  and training
  • Consulting
  • Sponsor Meetings
  • Project Team Meetings
  • Investigator Meetings
  • Newsletters

 

 

 
     
 






 
 
© 2008 CLINESIAN   Designed by :