Study Management

We believe that effective and proactive study management is critical to the success of a study. It begins with the correct study design for your product, then moves to the choice of an appropriate CRO to run the study for you, and then the real work begins. Nonclinical studies often employ multiple vendors, including bioanalytical support; we will manage all of the details to ensure a successful study.

Examples of essential study management activities:

• Pre-study: design, budgeting, request for proposal generation and contract/proposal review, CRO award, protocol development, test article management and shipping, lab personnel training, data template production
• In-study: technical support, data analysis and quality control, assessment of regulatory compliance, study monitoring, timeline management, troubleshooting, change order and protocol amendment review, sample shipment, vendor management of subcontractors
• Post-study: final data analysis and quality control, report authoring/review and finalization, management of materials disposition/archival, preparation of data for presentations and regulatory submissions