Project Management, Operations and Oversight. Develop timeline, manage vendors, anticipate and resolve problems, track protocol compliance, report project progress. As part of the normal course of conducting clinical trials, regular team meetings will be held with each vendor and held internally. This team is responsible for the project plan. Project progress and any issues relative to the project plan will be documented and addressed with the Product Development Team on at least a monthly basis. Regular conference calls with the TMTI will be established to review progress and results.
Project Management, Operations and Oversight. Develop timeline, manage vendors, anticipate and resolve problems, track project compliance, report project progress. As part of the normal course of executing project, regular team meetings will be held with each vendor and held internally. This team is responsible for the project plan. Project progress and any issues relative to the project plan will be documented and addressed with the Product Development Team on at least a monthly basis. Regular conference calls with the TMTI will be established to review progress and results.
Project Management, Operations and Oversight. Project management will oversee the CROs that are performing [+] process development and will also manage the in-house development effort
Project Management, Operations and Oversight. This element entails oversight and guidance of the development activities, as well as management of technical personnel.
Project Management, Operations and Oversight. Project management will oversee the CMO that is doing the CLIN0001 production.
Project Management, Operations and Oversight. As part of the normal course of outsourcing production, regular team meetings will be held and updates provided. Production oversight from site visits and data review will be shared and discussed. Regular conference calls with the CMO will be established to review progress and results.
Project Management, Operations and Oversight. Track progress and manage issues as they arise.
Project Management, Operations and Oversight. The antiviral team will meet regularly to review the protocol, monitor progress of the studies and evaluate observations. In addition, weekly conference calls with [+] will provide coordination of effort and timing.
Project Management, Operations and Oversight. Consideration as an [+] request managed by AVI regulatory affairs, using FDA compliant electronic templates, electronic document management and e-submission. Meeting arrangements and follow-up meeting minutes also managed by XX. Oversight is provided by XXX’s senior management.
Project Management, Operations and Oversight. Oversight of warehouse storage of drug product will be managed by AVI personnel through site visits, audits, and records review.
