|
Project Management.
ERGOMED’s Project Management ensures that all studies are
carried out in full accordance with the study protocol, to agreed
study timelines, and to other Sponsor-driven parameters. All operations
are carried out to full ICH/GCP and EU Clinical Trials Directive
regulations; Sponsor or ERGOMED SOP applicability is by agreement.
In addition, ERGOMED has experience of many registration and supporting
studies conducted under FDA IND regulations. Larger studies with
more than a few sites involved are normally assigned to a highly
qualified Project Manager with at least five years’ experience
to oversee the project. Reporting to the Project Manager will be
a staff of Clinical Research Associates (CRAs, or “Monitors”)
and Clinical Trial Administrators. A single, experienced Senior
CRA typically manages smaller studies.
Project Management responsibilities include:
• Maintaining primary contact with the Sponsor
• Taking overall responsibility for all procedures and processes throughout
the whole study period
• Selection and management of project team members (CRAs, as well as CTAs)
• Selection of sites/investigators in agreement with the Sponsor
• Set up and control of pre-study visits, site initiations, monitoring
and close-out visits
• Regularly reporting study status to Sponsors
• Overseeing preparation and distribution of newsletters to investigators
• Organisation of Project/CRA/Investigator/Client Meetings
|
