Clinical Research

Overview

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

Marcus Martin, PhD, MPH

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