Project Management

We manage your project, like you would, through your dedicated Project Teams!

Efficient Project Management is the key to successful conduct of a clinical trial. Timelines, cost, and quality are just as important when you outsource a study as when you manage it in-house. A process can only be as good as the people who manage it. We consider proactivity to be fundamental because proactive project management can identify risks and mitigate losses by timely resolution of issues. Hence, we have created a process that provides commitment, accountability, and anticipation.

At the onset of a clinical trial, a Clinical Project Manager is assigned to every study to manage the entire clinical trial process and act as a primary liaison to the Sponsor. A Project Manager is responsible for planning, implementation, and execution of the trial which is in line with sponsors expectation. The Project Manager is also responsible for maintaining effective and efficient communication with sponsors and sites to ensure delivery of high-quality services and client satisfaction throughout the project life cycle.

Project Management services at Vibgyor include:

• Project Plan development, Feasibility assessment, Investigator and Site selection
• Study set-up and site start up
• Organizing Investigator Meetings and Site training
• CRA resourcing, mentoring, co-monitoring support, and monitoring report review
• Third party vendor management
• Ensuring subject safety and regulatory compliance
• Managing study supplies and clinical site payments
• Managing Sponsor communications
• Ensuring that the trial team performance is compliant with all applicable regulatory requirements, project-specific SOPs, and
      industry best practices
• Managing client expectations for on-time and on-budget performance