CMC activities require close management and coordination, especially when success depends on outsourced activities. An optimal and timely program will reflect supply considerations, but also the connections between concurrent process development, method development, stability assessment, reference standard qualification, specification development and change control. At the start of a project, the PM can play a key role in establishing the project timing, resource and budget requirements, key deliverables and accountability. Risks and contingency plans are documented to support corporate planning. As activities proceed, the PM will organize meetings, work with team members to track progress and budget, obtain decision support when needed, and follow up with responsible parties. Deliverables and vendor performance are assessed before closing out activities and authorizing payments.
If a client has project management support for CMC activities, Alava team members can take care of the project tasks. If support is needed, Alava will supply an experienced CMC-focused project manager and help integrate CMC with clinical, regulatory and operational aspects of the project.