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 get those threads untangled.
For every aspect of a clinical trial – start-up, site management, supervising CRAs, communication with vendors, study progress reporting, database closure, our project manager will ensure you receive consistent results.
In our project management team, we nourish the culture of taking full personal responsibility. Our project managers have all study matters under their personal control. All project related tasks are completed with the project manager’s full involvement. The benefit of such approach is considerable – no task is left abandoned, no issue unattended, no request postponed.
We encourage our customers to involve our experienced Project Managers to involve in planning their studies at the earliest stage. That would allow to work out thoroughly prepared Project Plans including Monitoring Guide, Clinical Supply Chain Plan, Vendor Management Plan, Communication Plan, Safety Reporting Plan etc. as well as to optimize all study procedures and protocol design in concordance with local environment.
Close communication with all stakeholders as well constant support of study personnel, sites, vendors and Sponsors would ensure absolute control over the project progress and rapid response to the issues that arise in the course of the study.
Nothing else is as important as data integrity for clinical trial success. Our project managers are skilled and experienced in managing data cleaning in a timely fashion.
Communication between Sponsor and investigators is also crucial. All Sponsor initiatives, requests and instructions to participating sites are promptly delivered; any site requests or comments are immediately acknowledged, responded to or escalated to Sponsor.
We take care of minimizing 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. Project Managers ensure thorough documenting of communication with sites, all discussions, requests, provided information and actions taken and diligently report it to Sponsor.
Our managers value Clinical Trial Management Systems (CTMS) as well as other electronic clinical trial systems and treat it as their important task to maximize use of such systems and leverage benefits presented by the XXI century technologies. Not only do we get involved in using systems like that, but also act as consultants for investigators on sponsor’s behalf.
Thanks to PharmaSich Project Management Team our customers always enjoy smooth progress of their trials!