Regulatory Affairs/Clinical Coordinator Office

A key component providing efficient vector production services is to have procedures in place for ensuring the timely and effective transfer of materials, information and documents.  For clinical-grade materials it is also important to have a way of monitoring the use and disposition of released products.  The Clinical Coordination Office (CCO) performs a number of activities to prepare, transfer and track the status of clinical-grade products and documents.  These include; aiding investigators in preparing and submitting various regulatory documents, monitoring and tracking the use and disposition of released materials and documents and assisting clinical sites that use JVL materials for further manufacturing to maintain regulatory compliance.  The CCO liaisons with investigators, the FDA, the NIH and local regulatory groups (IRBs, IBCs) to efficiently communicate on issues concerning vector certification, release and clinical use.  The Clinical Coordination Office (CCO) is responsible for overseeing the interactions between the JVL, the investigator, the clinical site for the study and all regulatory stakeholders.  The overall function of the CCO will be to ensure that all applicable information is distributed to the appropriate recipients in a timely and efficient manner.  The CCO will also function to monitor the use of JVL products at clinical sites and to document any problems and/or adverse events involving JVL products.  The CCO will assist investigators and clinical sites to maintain regulatory compliance in the event that JVL products are used for further manufacturing such as ex vivo transductions of patient cells.