Clinical Research

Overview

2M’s Clinical Research Practice is led by Dr. Regina James, Vice President, Clinical Research.

Dr. James is supported by an interdisciplinary team that has the experience, knowledge, and expertise to manage phase I-IV domestic and international clinical trials, health services research, and epidemiologic studies.

Regina James, MD

Vice President of Clinical Research

Clinical Trials Management & Operational Support

  • Project management
    • Clinical monitoring
      • Feasibility reports
        • Investigational site operational assessment
          • IRB selection
            • Investigator meeting management
              • Subject recruitment planning
                • Site performance coaching
                  • Site initiation Routine monitoring
                    • Risk-based monitoring
                      • Centralized monitoring
                        • Study close-out
                          • TMF management

                          Clinical Data Management

                          • Paper-based or electronic data capture (EDC)
                            • Design and development of CRF/eCRF and CRF completion guidelines
                              • Development and programming of database and custom electronic edit checks
                                • Data verification and cleaning consisting of both manual and electronic review
                                  • Management, generation, resolution, and tracking of queries (DCFs)
                                    • Secure portal data view access
                                      • Interim closures as specified by project
                                        • Dictionary coding using standardized dictionaries (MedDRA, WHO-drug)
                                          • Standard metric reporting
                                            • Development of customized data reports
                                              • Standard or customized data transfers