When an emerging company progresses to the proof-of-concept trial, the stakes are higher to complete the trial as quickly as possible, without compromising quality. Senior level clinical direction now becomes more critical, but the company may begin to consider expanding its own clinical team instead of outsourcing the entire program. Halloran can fill the senior level gaps as well as hiring and managing the team to get the trial done. Halloran’s scope of services in Phase II include:
MANAGE PHASE II CLINICAL TRIAL
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Select and manage vendors
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Hire and manage sponsor study team
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Manage completion and execution of clinical trial protocol
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Select and oversee sites
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Build site relationships
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Manage subject recruitment
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Ensure quality of data, manage completion and reporting of studies
PHASE III PROTOCOL PLANNING
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Protocol input
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CRO and vendor assessment and selection
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Soft site start-up consulting
EXPAND CLINICAL OPERATIONS INFRASTRUCTURE
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Continued development of SOPs, forms, tools, and templates
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Evaluation of Clinical Trial Management System
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Exploration of resourcing options for Phase III
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Develop/deliver targeted training to team