Project management is a carefully planned and organized effort to accomplish a specific (and usually) one-time objective. Project management includes developing a project plan, which includes defining and confirming the project goals and objectives, identifying tasks and how goals will be achieved, quantifying the resources needed, and determining budgets and timelines for completion. It also includes managing the implementation of the project plan, along with operating regular 'controls' to ensure that there is accurate and objective information on 'performance' relative to the plan, and the mechanisms to implement recovery actions where necessary.

Each trial is assigned a dedicated lead who serves as the primary point of contact and creates and manages the project team from all functional areas.

Every project at CLINNOVO RESEARCH LABS is managed for success. Effective project management is a major key to realizing a sponsor’s objectives, including study details, timelines, and important regulatory considerations. CLINNOVO RESEARCH LABS has a history of clinical trial management. Each trial is assigned a dedicated lead who serves as the primary point-of-contact to spearhead and coordinate the activities of all functional areas. The project manager works closely with the sponsor to ensure that the trial is effectively driven to completion.

The project manager monitors and coordinates all aspects of a clinical trial, ensuring that relevant information is promptly relayed to sponsors. Project teams provide input into protocol and CRF design, report trial status on a periodic basis, and coordinate tangential services, including core laboratories. Project managers also work to meet timelines and business milestones.

Project management includes:

• Delivery of a completed project scope of work
• Oversight of all study-related activities
• Facilitation of communication between the sponsor and team members
• Development and management of study timelines and milestones, budgets, and deliverables
• Review of study deliverables, including the CRFs, CRF completion guidelines and all reports
• Coordination of attendance at investigators meetings
• Coordination of requests, including statistical analyses for presentations or publications and regulatory body responses