By: Ce3 Inc  09-12-2011
Keywords: Project Management, Clinical Development


Project Management

CE3 project managers are experienced team leaders focused on providing on-time, on budget results, whether managing a single service or a full-service clinical program. Our project managers develop a strong relationship with you and your team based on clearly identifying and mutually agreeing to all study objectives.

CE3 Project Managers:

  • • Serve as a primary resource and point of communication for the project team
  • • Provide leadership and direction to the project team and our clients
  • • Ensure CE3 systems and processes are adhered to assuring both efficiency and accuracy throughout the project
  • • Review and monitor study quality metrics
  • • Employ an active risk management perspective to resolve issues with thoughtful consideration
  • • Manage proactively, being flexible in their approach without compromising SOP compliance

Clinical Study Monitoring

CE3 CRAs are experienced monitors and are fully trained on all aspects of each program's design, objectives, and challenges to ensure consistent communications with our sponsors. We have a strong concentration in Oncology with a depth of experience that allows our monitors to ramp up on assignments rapidly.

CRAs communicate regularly with Investigators and investigative sites to verify patient enrollment, review study progress, answer protocol questions, discuss CRF completion and ensure the study is moving forward on time and as planned. Our CRAs are intimately involved in the data review process so their commitment to data quality impacts them directly.

Medical Management/Safety Reporting

CE3 has medical resources on staff, and can provide full Medical Monitoring services. An experienced physician provides medical consultation and support to our clients, CE3 clinical development staff and the study site staff. The Medical Monitor works closely with the Project Manager concerning all medical and safety issues to ensure adherence to all reporting requirements for adverse events. CE3 can report all serious and/or unexpected adverse events directly to our clients or to appropriate regulatory authorities, as necessary.

Study Quality Metrics

The complexities of drug development and clinical study activities require constant monitoring of numerous key variables to assure adherence to project timeliness and provision of high quality data. CE3 continually measures key variables and metrics of each study it conducts. We continually seek ways to improve the results we deliver to our sponsors.

Study Quality Metrics provide Sponsors with quantifiable measures of study progress and provide the Sponsor and CE3 study management team with tools to work together to insure the delivery of services and the highest of quality data products that meet or exceed our sponsors' expectations.

Keywords: Clinical Development, Project Management

Other products and services from Ce3 Inc



Whether your project is a specific regulatory submission, a complement to your clinical trial management or a full service program, CE3 generates a seamless solution at the highest level by integrating collaboration, experience, efficiency and excellence in every deliverable. EDC or Paper CRF development.