Affinity Bio Partners is pleased to offer the clinical trial services mentioned below and to provide the transformational foundation for our clients that leverages our visionary, industry leading, professional staff. ABP provides itself in working with clients that have been in clinical research for decades, newly developed biotechs/nutraceutical, medical cannabis and CBD companies, rescue studies. With our entrepreneurial foundation, we always are forward thinking, risk anticipation and mitigation we are the best partner for small to midsize companies.
Services include but are not limited too:
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Clinical Operations (Clinical Leads, Senior CRAs, Project Management, Clinical Study Assistants)
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Subject Recruitment and Retention with the utilization of AI Health Outcomes' Artificial Intelligence Patient Recruitment and Retention Technology, Patient Concierge services Services as well as the CannaBot™ and DrBot™
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Clinical Monitoring
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Clinical Site Management
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Medical Writing
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Study Start-Up Activities
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Drug Safety, Biostats, Data Management services (with our partner)
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Clinical Quality Auditors
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Clinical SOP Development, Training and Implementation
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Merger and Acquisition Due Diligence/Strategic C-Level Executive Leadership and Consulting
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SOX Compliance Adherence & Preparation for Sponsors to go public
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Site fiscal compliance & the National Coverage Decision; the impact on Sponsor timelines, budgets & site agreements
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Global SMO/Site Agreement, Investigator Initiated Study Negotiations, Management and Payment Services
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Investigator Initiated/Sponsored Study Budgets & Contracts
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Medicare Coverage Analysis and National Coverage Decision analysis
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Global Outsourcing and Procurement Negotiations, Management and Payment Services, Service Provider Relationship Management/Governance and Functional Leadership
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Development of SOP/Processes for Outsourcing and Site Contracting
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Meeting Planning Services
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Marketing and Product Development
