SERVICES
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Project Management and GLP Training• Team Facilitation • Timeline Development and Management • Budget Management • SOP Development • Archival Support • GLP Training
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CRO Qualification and Study Monitoring• CRO Audit Follow-up • CRO Management/Liaison • GLP Compliance • Study Monitoring and Protocol Compliance • Study Monitoring Training
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Protocol and Report Review and QC• Requests for Proposals • Protocol Development and Review • Nonclinical Study Documentation • Data Integrity Review • Report Review and QC
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Regulatory Submissions• Generation of Tabulated Summaries • Module 2 and Module 4 QC • IND QC • IND Annual Updates • Regulatory Operations • Update of ClinicalTrials.gov Site • Safety Reporting Preparation