The Project Manager (PM) is the primary C5Research contact for those involved in the conduct of the trial. From the sponsor to the site, and everyone in between, they engage in proactive and regular communication. The PM can conduct investigator meetings and coordinator conference calls, address "lessons learned", share experiences of best practices across sites, and provide “peer-to-peer” communication with site coordinators.
C5Research Project and Site Managers are well-versed in Good Clinical Practices and ICH guidelines. All of our Project Managers maintain current CITI training to ensure that they are up to date on research regulations and can advise our sponsors and investigative sites on the most current guidelines. The Project Management team members have years of clinical practice experience. Many of our Project Managers have been clinical instructors, clinical nurse specialists, nurse managers and clinical faculty, bringing a wealth of clinical practice expertise. This provides essential input into the trial design and feasibility of clinical trials.
Data Safety Monitoring Board, Executive and Steering Committees
C5Research assists in the selection, management and coordination of Data Safety Monitoring Boards (DSMB), Executive Committees (EC) and Steering Committees (SC), and creates the charters/guidelines to operationalize these committees.
Site Selection and Management
C5Research maintains a growing site database of experienced clinical research sites who can be considered for trial participation. C5Research works closely with the Sponsor to develop protocol-specific criteria to identify and select study sites. We draw on our past experiences and the relationships that we’ve developed with investigators and study coordinators, to discuss and evaluate their potential for successful participation in each new trial.
Our Project Managers’ considerable experience allows them to work collaboratively with all project team members to proactively educate study staff on critical trial milestones, support recruitment and retention efforts, serve as a resource for data entry and query resolution, and to serve as a clinical resource for patient management. All of our Project Managers have been study coordinators. We are able to provide a 24-hour clinical hotline to allow for immediate access for subject management or other urgent protocol questions.
C5Research Project and Site Managers are able to support the Sponsor and clinical investigators by developing a comprehensive educational platform to support the trial. Development of educational presentations for study investigator meetings, study coordinator webinar and teleconferences help to support the sites throughout all phases of a trial. In addition, study and patient facing tools, newsletters and reference materials are developed as part of our strong focus on education throughout the trial.