Our experienced Project Managers serve as the single point of contact for the study sponsor. Each has therapeutic expertise and is chosen to lead a clinical endpoint study based on his or her specific knowledge base. They lead the study team through each step of the process, from protocol design, selection of qualified investigator sites and oversight of third-party vendors to coordination of statisticians, data managers, medical monitors, clinical research associates and medical writers. The involvement of the Project Manager from the strategic planning stage through to the production of the final report ensures proper execution, the highest-quality deliverables and timely completion of each clinical endpoint study.
Our experienced Project Managers and our skilled Clinical Research Associates work together as a team to efficiently manage site activity.
Novum Monitoring Services include:
- Conducting on-site Pre-Study Site Selection and Site Initiation review
- Monitoring on-site Source-to-CRF verification
- Reviewing documents to ensure regulatory compliance
- Reviewing study drug for appropriate handling
- Resolving Data Queries
- Reporting findings to the Project Manager
- Maintaining Trial Master File
Our team concept allows our Project Managers to manage a study from beginning to end and maintain real-time knowledge of the activities occurring at all sites throughout the clinical endpoint study, while allowing our CRAs to focus on the specific needs of individual sites to ensure the successful completion of each study. In addition, sponsors may contract our monitoring services for Early Phase studies conducted in our clinics.