Overview

2M is equipped to provide our clients with clinical research and operational support for Phase I-IV domestic and international trials.

Regina James, MD

Clinical Research Contact

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