Project Management Services

ClinDatrix will appoint a Clinical Project Manager to be the Team Leader for each clinical investigation. The Clinical Project Manager will lead the team of professionals consisting of Clinical Research Associates (CRAs), Data Managers, Statisticians, Medical Writers, and Regulatory Associates. Team members may be client staff members, or ClinDatrix staff members, contractors and/or consultants. The Project Manager will promote interaction, clarify team member responsibilities, and ensure accountability by individual team members as well as by the Project Team as a whole.

  1. Interaction with IRB's

    2. ClinDatrix will interface with local and or central IRBs to ensure that IRB submissions are complete and are reviewed in a timely fashion.

  2. Contract Management

    3. ClinDatrix will provide contract management to the sites. We will track, oversee, and execute contract/grant payments.

  3. Outsourcing Management

    4. ClinDatrix will manage contractors and will oversee and manage central laboratories, local laboratories, and independent consultants.

  4. Planning and Tracking

    5. ClinDatrix will work with our clients to establish and maintain study milestones throughout the course of a clinical investigation.

  5. Develop Monitoring Strategy

    6. ClinDatrix will develop a customized monitoring strategy for the clinical trial and determine the number of monitors required, the scheduling and frequency of monitoring visits, and the duration of the clinical site visits.

  6. Efficient Data Flow

    7. Working in conjunction with our clients, ClinDatrix will engineer an efficient data flow system that will integrate CRF and Query flow between clinical sites, CRAs, Sponsor, ClinDatrix Project Management, and Data Management.

  7. CRA Training

    8. Collaboratively with our clients, ClinDatrix will develop protocol specific training for the CRAs assigned to the clinical trial. This training will include the background scientific history for the conduct of the clinical trial, a focus session on the therapeutic indication, specific protocol requirements, and detailed review of completion of the CRFs. Practice and hands-on sessions, will reinforce the training presentations.

  8. Trip Report Review and Submission

    9. The ClinDatrix Clinical Project Manager will review the monitoring trip reports prepared by the CRAs. Trip reports will be collected, reviewed, and submitted to the client by the ClinDatrix Clinical Project Manager.

  9. Quality Assurance

    10. ClinDatrix will ensure quality monitoring performance by “monitoring the monitor.” CRAs will be monitored to ensure adherence to Standard Operating Procedures (client’s or those of ClinDatrix) and to Protocol Specific Procedures.

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