Last week, a globally active, privately held, mid-sized contract research organization (CRO) claims its research site is the very first one to dose a subject for the Janssen (J&J) ENSEMBLE study, the large, Phase 3 clinical trial investigating the vaccine candidate now known as JNJ-78436735. The company declared it was the clear lead enroller in this early part of the study, randomizing dozens of volunteers in the first week of the study. This dosing of the first study subject represents an important trial milestone. Moreover, the CTI Clinical Research Center (a trial site owned and operated by the CRO) received serious visitors last week as the top brass from the U.S. Government’s public-private partnership called Operation Warp Speed showed up there, including Dr. Moncef Slaoui, Chief Advisor and General Gustave F. Perna, Chief Operating Officer.
A Leading Trial Site
CTI’s recent press release was of course promotional in that the CRO is touting a considerable accomplishment as a marketing and industry awareness action. CTI’s CRC, a state-of-the-art facility based in Norwood, Ohio, just off the campus of Xavier University, runs Phase I-IV studies for sponsors. CTI emphasizes their priority of transparency and patient-centricity, ensuring that participants are well-informed and comfortable while staying there.
TrialSite emphasized that J&J secured $1 billion via Operation Warp Speed and BARDS for the procurement of 100 million doses of Ad26.COV2.S, (JNJ-78436735) Janssen’s vaccine candidate. At $10 per dose, the initiative is led by one of the heavy-hitting pharma executives, Paul Stoffels.
During the Operation Warp Speed leadership visit to the CTI trial site operation, led by Dr. Antoinette Pragalos, principal investigator, Mr. Slaoui commented, “I’ve been extremely impressed by the work I’ve seen being done in [the pharmaceutical] industry.” He emphasized, “The people in this industry are saving lives every day, and most of us don’t even know it.”
CTI on the Move
CTI is currently managing over 20 active COVID-19 clinical trials for treatment and prevention in addition to their ongoing work involving community support since the economic contagion due to the pandemic and subsequent shut downs.
CTI positions itself as one of the 20 largest CROs worldwide, working with associates in over 60 countries across six continents. According to the company’s recent press release, it was named the #1 CRO in the world for quality at the 2020 CRO Leadership Awards, outperforming nearly 30 other recognized CROs from around the world.
Dr. Antoinette Pragalos, MD, Internal Medicine, Principal Investigator