Common use of Program Management Services Clause in Contracts

Program Management Services. ● Lead and support strategic planning to complete a Phase I (First Time in Humans [FTIH]) clinical study and, where possible, proof of concept clinical studies ● Project Plan Development o High level strategic plan and timeline o Detailed plan, timeline and budget ● Project Management o Set goals and define responsibilities of team members o Coordinate core project team meetings o Attend, coordinate and support functional project team meetings if required o Review and update of project plan and budget at regular intervals or as required o Follow up action items with team members o Risk assessment and mitigation strategies ● Provide development services or support and identify outsourcing to service providers for services including, but not limited to: o Preclinical (non-clinical) toxicology studies o ADME o Functional ingredient sourcing/qualification/characterization/supplier site auditing o Excipient sourcing/qualification/characterization/supplier site auditing o Clinical trial batches (CTM batches) manufacturer o GLP/GMP testing laboratories ● Evaluate service providers including preparation of “Request for Proposal” details, reference checks, auditing, evaluation of proposals, recommendations and contract negotiation. ● Recruit experts to support the development program for strategic planning, protocol development, regulatory document preparation and filing, preclinical studies, material characterization and CMC development.