Affinity Bio Partners, Llc

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