Although two vaccines (Pfizer/BioNTech and Moderna) have been approved under emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), two more major vaccines are under investigation, and trial site organizations, such as Headlands Research Orlando are busy recruiting participants. Looking for more participants, activity trial site organizations are well accustomed to, yet continue to, at times, struggle with showcases the importance of volunteer participation for COVID-19 vaccine research. The Central Florida-based trial site organization understands the importance of continuing COVID-19 vaccine research. Why? Well, first, more research needs to be done on how long these various vaccines may last and whether a person is still contagious post-vaccine administration. Moreover, the healthcare market generally benefits from competition: the more safe and effective vaccines targeting this dangerous pathogen, the better. More research participant engagement drives more data and greater insight and evidence for the ongoing war against COVID-19.
Led by Dr. Chris Galloway as Principal Investigator, he recently interacted with local media WFTV 9 ABC in Orlando.
According to a recent news article in the San Francisco Bay Area, Headlands Research is collaborating with both AstraZeneca (Oxford vaccine) and Janssen (Johnson & Johnson) to recruit participants for mission critical COVID-19 vaccine studies.
Headlands Research Orlando, Part of the umbrella organization Headlands Research, emphasizes the importance of multiple vaccine candidates to fight the COVID-19 pandemic. Principal investigator Dr. Galloway recently shared with the local press, “We want people to come for the right reasons.” The doctor pointed out, “That they are looking to help participate, that it’s their choice, and there are no other motivations.” Once the research team qualifies and enrolls and then administers the experimental vaccine from either AstraZeneca (AZD1222) or Janssen (Ad26.COV2.S), the Principal Investigator noted that the team then monitors the participant for any adverse reactions, then the subject is sent home to self-monitor. Of course, the Headlands Research team keeps in close contact with the subject to track for any changes.
The Janssen (J&J) study (NCTT04505722), investigates that company’s investigational vaccine known as Ad26.COV2.S which requires only one dose. Targeting up to 60,000 in a multiyear study, this vaccine product has the potential to take over the market as it only requires one dose.
While AstraZeneca, at one point, was considered to have the lead investigational vaccine product known as the “Oxford” vaccine (ChAdOx1 nCoV-19), now called AZD1222. Their study (NCT04516746), set back due to reported neurological adverse reactions by a couple of participants in the United Kingdom, resumed and is now working to make up time.
Headlands Research: Emerging ‘Super Trial Site’ Operation
With many trial site locations across the USA, Headlands Research positions itself as a leading globally integrated clinical trial site organization with the mission of dramatically improving the clinical trials process.
Back on July 16, the trial site organization announced that it was selected for numerous upcoming COVID-19 vaccine trials. They have built an industry-leading position in the vaccine and infectious disease space, successfully conducting over 250 vaccine, prophylaxis and treatment trials to date across its North American sites.
Based in San Francisco and backed by leading global investment firm KKR, Headlands falls in the category of “Super Trial Site organization, that is backed by private equity with a mission to grow and consolidate trial site locations across North America. With at least 11 trial site locations, Headlands Research operates in the following locations:
- Toronto, Canada
- Stockbridge, GA
- Fayetteville, GA
- Orlando, FL
- Lake Worth, FL
- Sarasota, FL
- Lake Charles, LA
- Houston, TX (North)
- Houston, TX (South)
- Brownsville, TX
- McAllen, TX
Headlands Research was founded on the belief that clinical trial research needs to significantly evolve to better match the current healthcare climate, as well as the real-world needs of patients. Its mission is to profoundly change the clinical trials process by integrating novel technologies into a platform of best-in-class research facilities that gather high-quality data via increased trial participation while addressing specialty populations that are underserved (e.g., rural populations, racial and ethnic minorities, the elderly, etc.).
As TrialSite reported in July, Headlands Research continued ongoing consolidation in the trial site organization space. In this case, the firm expanded, thanks to private equity money by merging two large central nervous system (CNS)-focused clinical research centers, including JEM Research Institute and Toronto Memory Program.
By Nov. 2019, Headlands Research purchased six trial site locations in one KKR-backed deal. TrialSite reported that institutional capital was now concentrating on clinical investigational sites in a bid for the ongoing scouring for merger and acquisition activities as trial site consolidators such as Headlands Research sought scale, diverse therapeutic capabilities and patient access to help promote and to grow business with CROs and biopharmaceutical sponsors.
Headlands Research is led by a sophisticated leadership evidencing the evolving stakes involved with the management and growth of trial site organizations.
Lead Research/Investigator Headlands Research Orlando
Call to Action: If you are based in the Orlando area and want to contribute to ongoing COVID-19 research reach out to Headlands Research Orlando.