Christina DiArcangelo is an entrepreneur and CEO with over two decades of expertise in the medical cannabis, biotechnology, pharmaceutical, nutraceutical, and medical device industries. Her commitment to improving patient care is unrivaled. Christina has been involved with revolutionary projects and global clinical studies that positively impact patients through her roles as CEO of Spectral Analytics Precision Tele-Monitoring, Founder and CEO of Affinity Bio Partners, Board President and CEO of Affinity Patient Advocacy, and CEO & Co-Founder of AI Health Outcomes.
Below are highlights of the interview conducted between World’s Leaders and Christina DiArcangelo:
Describe who you are as a person, inside and outside of the workplace.
empathetic, helpful, team player, spiritual, intuitive, creative, problem solver, thinks outside the box, sees the big picture, reflective, speaks up, wants to motivate others, tenacious, determined, motivated, help patients, provide people with a voice when they may not feel they have one, compassionate, caring, loving, transparent, and loyal
Describe your background and what did you do before you started/joined the company?
I started working as a paralegal when I got out of college the first time and interviewed for the first global clinical research company (CRO) 23 years ago. Once I started working at the CRO, I decided to stay in the biotech, pharma, and medical device industries.
Tell us about the inception of the company. How did it all start?
Affinity Bio Partners was my second CRO that I started. My first CRO was Armonia Clinical Research, which I launched in 2010 but started in 2009. Rather than rebranding to start a new global CRO and offer additional services like due diligence for investors that are looking to invest in a biotech/pharma/device company, I launched a new company. I also became a global organization and started working on global studies.
What has made you successful? What do you value?
I feel like my father’s work ethic and the exposure that I had to politics, labor relations, labor negotiations, and contract negotiations gave me an incredible foundation. My late father, Albert J. DiArcangelo, Sr was truly the voice of the blue-collar individuals that he worked with. Having had the exposure that my father provided to me, I was able to learn the necessary skills that I utilize today in doing business. I have also had the opportunity to gain several professional and personal mentors over the years. I value patients having the opportunity to take medicines that have been studied completely and having the ability to ask questions and have access to solutions that will help them feel better. People deserve to be taken care of properly.
What are the major services of the company and how do they help the company to get ahead in the competition?
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, as well as the CannaBot™ and DrBot™
- Clinical Monitoring
- Clinical Site Management
- Medical Writing
- Study Start-Up Activities
- Drug Safety, Biostats, and 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 impact on sponsor timelines, budgets, and 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 and Governance, and Functional Leadership.
- Development of SOP/Processes for Outsourcing and Site Contracting
- Meeting Planning Services
- Marketing and Product Development
What value-added services does the company provide?
I have a thorough understanding of the patients that sponsors are trying to recruit based upon the in-depth knowledge that I have since I have become a patient advocate through my patient advocacy firm, Affinity Patient Advocacy. I truly understand the patient’s needs.
What are the most important aspects of a company’s culture?
Transparency, following the law, working with the highest ethical integrity, and always ensuring patient safety.
What principles do you believe in and how do you build this culture?
Training, teaching, and staying current on industry topics and sharing information freely within the organization are all part of training. I believe that ensuring that you focus on all the talents of your staff and enabling them to use their talents is very important. Management needs to roll up their sleeves and work collaboratively.
What is the significance of innovative ideas in the company?
We are constantly pivoting based on business needs. Five years ago, I forged ahead into the medical cannabis and cannabinoid global research space. This was a time when most traditional executives, like myself, were not supporting this industry. The stigma attached to working in medical cannabis and cannabinoid global clinical research was fierce. People judged.
What are your responsibilities as the Founder/CEO/Managing Partner of the company?
Hiring, business development, providing many of the services mentioned above, and formulating new products.
What advice would you give someone going into a leadership position for the first time?
Listen to your team, not to respond, but to really listen. You need to conduct yourself in a manner that you would want your team to also do.
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