Megan Cole's Colleagues at Affinity Bio Partners
Megan Cole's Contact Details
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Charlotte, North Carolina
Affinity Bio Partners
Megan Cole's Company Details
Leading mid-size CRO working in biologics, device and medical cannabis.•Clinical Operations (Clinical Leads, Senior CRAs, Project Management, Clinical Study Assistants)•Clinical Monitoring•Medical Writing•Study Start-Up Activities•Drug Safety•Clinical Quality Auditors•Clinical Site Management Operations•Clinical SOP Development, Training and Implementation•Merger and Acquisition Due Diligence, C-Level Executive Strategic Consulting•SOX Compliance Adherence & Preparation for Sponsors to go public•Site fiscal compliance & the National Coverage Decision; the impact on Sponsor timelines, budgets & site agreements•Global SMO/Site Agreement, Investigator Initiated Study Negotiations, Management and Payment Services•Investigator Initiated/Sponsored Study Budgets & Contracts•Medicare Coverage Analysis and National Coverage Decision analysis•Global Outsourcing and Procurement Negotiations, Management and Payment Services, Service Provider Relationship Management/Governance and Functional Leadership•Development of SOP/Processes for Outsourcing and Site Contracting•Staff Recruitment•Meeting Planning Services