Project Management: overview

When a project kicks off, paper plans vanish, leaving place to risk mitigation and issues resolution. In the real-life environment of complex dependencies, risks have to be foreseen and tasks coordinated. That’s when our managers will get those threads untangled.

During study set-up, IMP depot shipments, site communication, central lab test samples handling, reporting, database closure and queries resolution, our project manager will ensure you receive consistent results.

In our team of dedicated managers, we nourish the culture of taking full personal responsibility. Our project managers have all trial related matters under their personal control. All project related tasks are initiated, estimated and corrected with the managers’ full involvement. The benefit of such approach is considerable – no task is left abandoned, no issue unattended, no request postponed. This principle is in tune with the spirit of GCP where the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.

Close communication with sites and constant support of investigators ensure rapid response to inquiries. In the event of requests for data clarification, we will check and validate data in a timely fashion to ensure clean results. All sponsor-initiated communication to participating sites is promptly delivered; any site requests or comments are acknowledged and responded to.

We take care to minimize communication barriers – for the most part our CRAs speak the same language as investigators. We also work proactively to eliminate possible “difficulties of translation” when it comes to protocol text, procedures description, lab kits markers, paper or electronic forms, etc.

Most sponsors have their Clinical Trials Management Systems (CTMS) on-line today, where communication with sites is accumulated, inquiries and requests are registered, provided information and actions taken recorded. Our important task is to maximize use of such systems and leverage benefits presented by integrated data. Not only do we get involved in using such systems, but also act as consultants for investigators on sponsor’s behalf.