Affinity BioPartners, LLC  |  Chester Springs, PA  19425 , Campbell, CA 95008|  info@affinitybiopartners.com

© 2017 Affinity BioPartners, LLC 

Clinical Research Services

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:

  • Clinical Operations (Clinical Leads, Senior CRAs, Project Management, Clinical Study Assistants)

  • 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™

  • Clinical Monitoring 

  • Clinical Site Management

  • Medical Writing

  • Study Start-Up Activities

  • Drug Safety, Biostats, Data Management services (with our partner)

  • Clinical Quality Auditors

  • Clinical SOP Development, Training and Implementation

  • Merger and Acquisition Due Diligence/Strategic C-Level Executive Leadership and 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

  • Meeting Planning Services

  • Marketing and Product Development

Clinical Research and Trial Design

We strive to assist our client partners in the development of their clinical trials that are effective, executable, safe and easy to enroll.  Due to the extensive magnitude of the clinical trials that ABP has conducted, our partners will realize our passion and attention to detail is not only best-in-class but monumental compared to that of our larger corporate competitors. This has been illustrated in the countless "rescue studies" ABP has conducted.  These findings have all be documented in our knowledge base and will facilitate your organizations ultimate success from the beginning of our engagement, rather than after issues arise.  

Conducting Clinical Trials and Research

Once the clinical trial design has occurred, our next focus will be implementing the clinical trial activities in a swift and expeditious manner.  ABP does not have multiple layers of management to sift through.  The attention to detail applied during our partner's study is unprecedented compared to that of other larger corporate Clinical Research Organizations, and begins from day one of our engagement.   ABP's corporate model is to ensure that the "High Touch Approach" is at the core of our service offerings creating synergies that allow seamless integration with the clients' enterprise-wide teams.  ABP is able to recruit subjects more quickly with the utilization of HCXP's AI Patient Recruitment and Retention Technology as well as retain the patients with our Patient Concierge Services.

Product Development and Marketing Strategy

Marketing your new product is a critical component to your market success.  ABP offers not only Clinical Research Organization services, but enterprise-wide services as well. 

The following services are but just a glimpse at the additional services our partners will receive when becoming an ABP partner:

  • New product Marketing

  • Corporate Strategic Planning

  • Public Relations Services

  • Social Network Strategic Planning and Administration

  • Government Relations

  • Lobbying

  • and much much more