The main Study Start-Up activities:
- Perform high-quality feasibility for the clinical study
- Identify and qualify sites and investigators
- Prepare documentation for IRB and/or Ethics Committee approval
- Initiate or assist in budget negotiations with the sites
Main Study Execution activities:
- Track overall study progress and progress of individual sites.
- Deliver customized reports (so-called Dash-board) for your team with critical study metrics, including deviations, enrollment rates, and adverse events with trend analyses.
- Develop a randomization scheme and either paper or web-based subject randomization system
- Represent sponsor with regulatory agencies if required
Specifics for ESAIC Project management
Lead Project Manager:
ESAIC will assign a Lead Project Manager who will be the primary point of contact for ESAIC. The Lead Project Manager will provide regular and detailed updates of the study status and progress.
In case the sponsor proposes a study protocol, ESAIC will still perform an independent review of the protocol methodology and implement the findings accordingly.
The ESAIC project manager, in collaboration with Chief Investigator, will organize a project team Kick-off Meeting as soon as possible. The Lead Project Manager will collaborate closely with the sponsor(s) to coordinate the meeting’s logistics and agenda.
During the Kick-off Meeting, the ESAIC Lead Project Manager and sponsor(s) teams will discuss and agree to the approach, key milestones, and deliverables included in the project.
The Lead Project Manager will participate in periodic project teleconferences with the sponsor(s) during the study. ESAIC will provide agendas and minutes to be reviewed by the sponsor(s). Teleconference minutes will be filed in the study TMF and will be used to document the study’s progress and topics and action plans discussed.
The ESAIC network of investigators will assign per project a Chief Investigator and, per country, National Coordinators.
These investigators are well trained and experienced researchers. They are available to assist in coordinating for screening potential patients, providing expert training to other study staff, etc.
The Chief Investigator will be directly involved in:
- Protocol design
- Site selection and contracting
- Recruitment follow-up and monitoring
- Data safety monitoring board organisation
- Steering committee coordination
Data Management: Data Quality and Validation
For the ESAIC clinical study data management activities, reliable data collection is key in producing a quality study. Our ESAIC Data-management team can assist investigators and clinical study coordinators with developing E-CRF procedures and protocols to verify the validity of the data collected, thus ensuring the quality and validity of the data from the start of the study till the analysis phase.