The Project Manager (PM) is the primary C5Research contact for those involved in the conduct of the trial. From the sponsor to the site, they engage in proactive and regular communication in partnership with the sponsor and study team. As the primary C5Research operational lead involved in the conduct of a clinical trial, members of this team represent the key partner support and regularly collaborate with our physician leadership, academic committees, site investigators, sponsors and CROs.
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.
Our primary strengths include
- Development of real-world protocols that consider both the patient and site experience, while considering efficiency of implementation and cost.
- Provision of education, training, and communications that engage the sites, study participants, Clinical Research Associates, and the operational team.
- Selection and management of academically lead governance committees in collaboration with the sponsor which adds credibility to the study.
- Strong relationships with academic thought leaders globally.
- Independent trial collaboration to ensure success through each phase of the trial.
- Proactive problem-solving addressing advances in clinical management, recruitment and retention to minimize risk throughout the trial.
Data Safety Monitoring Board, Executive and Steering Committees
In collaboration with the sponsor, C5Research assists in the selection, management and coordination of Data Safety Monitoring Boards (DSMB), Executive Committees (EC) and National Coordinator Steering Committees (SC), and creates the charters/guidelines to operationalize these committees. 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 Identification, Selection and Management
C5Research maintains ongoing relationships with experienced U.S. 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. Depending on the scope of the trial, C5Research can provide U.S. based site management including regulatory support in lieu of a CRO.
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.
The C5Research PM team can contribute study specific performance standards, an approach adopted by the FDA, to drive the quality of our trials and ensure that the results are scientifically meaningful and of the highest quality.
C5Research Project 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 In addition, study and patient facing tools, newsletters and reference materials are developed as part of our strong focus on education throughout the trial, leveraging the resources of the Cleveland Clinic Heart, Thoracic, and Vascular Institute. These educational contributions enhance the standard approach to a sponsor/CRO partnership, providing innovative and clinically relevant content which differentiates the trial for the sites. The materials are tailored specifically to the trial and allow for professionally prepared materials to support recruitment, retention, and patient engagement eliminating the need for separate vendors.
The PM can develop and manage investigator meetings and coordinator conference calls, address "lessons learned", share experiences of best practices with the study teams, using the expertise developed from like trials.