CenExel Clinical Research Acquires CITrials

Salt Lake City, Mar. 9, 2021 /PRNewswire/ — CenExel Clinical Research, Inc., (“CenExel”) announces the acquisition of CITrials, a southern California-based clinical research firm with three sites serving Los Angeles, Orange, and Riverside/San Bernardino counties. CITrials conducts Phase I through Phase IV studies in mental health and internal medicine disorders, with adolescent, adult, and geriatric populations.

This strategic acquisition allows CenExel to augment its core strength in psychiatric and neurological research and provides further integration opportunities with Anaheim Clinical Trials (ACT), another Center of Excellence site in southern California.

The CenExel Centers of Excellence network now encompasses eight of the most experienced clinical research facilities in the country, with special emphases in Neurology, Pain, Psychiatry, Vaccines, Ethnic-bridging, and Sleep studies. Each of the CenExel research units have outstanding records of assisting pharmaceutical sponsors with protocol development, study design, and conducting Phase I-IV trials to develop new therapeutics for improved patient care.

Debra Hoffmeyer, founder and CEO of CITrials, is certified in clinical research and is a member of the Society for Clinical Research, the CNS Summit, National Clinical Drug Evaluation Unit (NCDEU), the National Institute of Mental Health (NIMH), and the Association of Clinical Research Professionals. The board-certified principal investigators at CITrials are affiliated with leading universities and hospitals in southern California, adding decades of clinical practice and more than 100 years of combined clinical research experience to the CenExel network.

“At CITrials, we are proud of the level of patient engagement in our studies, as well as our consistent ability to deliver accurate, timely results for our study partners,” said Debra Hoffmeyer. “Our mission and performance are ideal complements to the CenExel operating culture, and we see this as an important means of serving our clients with more single- and multi-site studies.”

“We are very pleased to have CITrials join our group of Centers of Excellence,” said Tom Wardle, CenExel CEO. “This addition expands our capacity in CNS research and will provide our customers with faster enrollment and quality results. CITrials and CenExel share a common passion to infuse consistent methodology, training, and data quality metrics in our studies. We will also take advantage of consistent and unform processes in study start-up, contracting, and regulatory documents, all using a common technology platform.”

Kevin Quinn, VP of CenExel Business Development and Integration, noted, “This acquisition continues our drive toward establishing CenExel as the preferred, full-service clinical research site network for sponsors and clinical research organizations.”

CenExel Clinical Research, Inc. was formed in 2018, and since its formation, CenExel has energetically pursued organic growth as well as the acquisition of other state-of-the-art research centers around the U.S.

The mission of CenExel is to work with trial sponsors and contract research organizations to reduce costs and development times for innovative therapies which may advance patient care.

Media Contact: media@CenexelResearch.com

 

About CenExel Clinical Research
CenExel Clinical Research (www.CenexelResearch.com) provides unparalleled medical and scientific support in the design and execution of clinical trials. Their attention to detail assures quality, reliable results and has helped CenExel to consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a great depth of experience and insight for the principal investigators and research staff in each facility. The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that clients achieve their clinical research goals.

 

 

Research Centers of America Expedite Broad Study on Moderna’s COVID-19 Vaccine

Hollywood, Jan. 7, 2021 /PRNewswire/ — Research Centers of America (“RCA”), a CenExel Center of Excellence, joined nearly 100 other clinical research facilities across the United States to test the safety and efficacy of Moderna’s mRNA-1273 vaccine against COVID-19. The published results in The New England Journal of Medicine showcased that the trial enrolled 30,420 volunteers and found an overall vaccine efficacy rate of 94.1%. Although moderate, short-lived reactogenicity occurred more often in the mRNA-1273 group, these reactions are typical for vaccinations. Severe adverse events were rare and occurred roughly as often between both the placebo and mRNA-1273 groups.

Dr. Howard Schwartz, Chief Medical Officer and Principal Investigator at RCA and a widely-published author, contributed the Center’s findings to the study as part of his authoring partnership for the article. “The data demonstrated strong safety and efficacy results from a novel mRNA COVID-19 vaccine,” he said. “These welcome and extremely positive indications are a breath of fresh air after a turbulent year.”

RCA and the entire 5-site CenExel network were uniquely positioned to move this study forward by relying on their profound experience in vaccine research and on-site labs for working with peripheral blood mononuclear cells (PBMC). Professional, full-time staff at these clinical trial facilities have conducted extensive research on vaccines for many viruses already, including seasonal and pandemic influenza, Ebola, smallpox, West Nile Virus, and Zika. The PBMC labs allow for the isolation, cryopreservation, and shipping of PBMC, which is essential for accurate results in a vaccine trial.

“Our whole site network has been able to participate in key studies in Operation Warp Speed,” said Tom Wardle, CenExel CEO. “In the past several years, our Centers have supported over 100 vaccine trials and surpassed recruitment goals by 110%. We have enrolled over 5,000 patients in six of the seven Operation Warp Speed studies, with 40% of the patients representing diverse minority groups. Throughout these efforts, we maintained the strictest safety measures and the highest quality of work.”

The mRNA-1273 vaccine was developed by Moderna and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), within the National Institutes of Health (NIH). The study was conducted between late July and October, 2020, with adjustments to the site selection and enrollment processes to maximize racial and ethnic minority representation among volunteers.

Media Contact: media@CenexelResearch.com

 

About Research Centers of America
RCA (www.RCATrials.com) is a privately-owned, multi-specialty research site that conducts Phase I – IV clinical trials. RCA inpatient and outpatient studies are made up of healthy and special populations ranging from pediatric to geriatric age groups. Our mission is to be the best-in-class clinical research site contributing to the development of new medications by conducting trials at the highest ethical standards. We are a CenExel Center of Excellence, assuring unparalleled patient engagement, staff expertise, and valuable results.

About CenExel Clinical Research
CenExel Clinical Research (www.CenexelResearch.com) provides unparalleled medical and scientific support in the design and execution of clinical trials. Their attention to detail assures quality, reliable results and has helped CenExel to consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a great depth of experience and insight for the principal investigators and research staff in each facility. The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that clients achieve their clinical research goals.

 

 

CenExel Clinical Research Joins Decentralized Trials & Research Alliance (DTRA)

Salt Lake City, Dec. 10, 2020 /PRNewswire/ — CenExel Clinical Research (“CenExel”) has joined an alliance of fifty life sciences and healthcare organizations that seeks to accelerate the broad adoption of patient-focused, decentralized clinical trials and research. The Decentralized Trials & Research Alliance (DTRA), which launched December 10th, 2020, plans to unite industry stakeholders, including healthcare companies, regulators, patient groups, and research organizations with a singular mission to improve trial accessibility by advancing policies, research practices, and digital-health technologies in clinical research.

CenExel CEO Tom Wardle said, “We’re pleased to be a founding member of the DTRA and believe that it provides a crucial platform for industry collaboration to expedite patient access to clinical trials, as well as advance the broader use of digital technology in patient engagement, data collection, and the management of research results.”

“We are gratified to welcome CenExel to the Decentralized Trials & Research Alliance,” said Amir Kalali, MD, founder of several collaborative life science communities and co-convenor of DTRA. “By advancing decentralized research, we can make the clinical trial process more patient-focused, increase trial efficiency and encourage use of technologies. We are excited by CenExel’s commitment to embracing decentralized trials and to changing the culture that has been a rate limiter to innovation.”

Experts estimate that COVID-19 may set non-pandemic clinical trials back by several years due to patients’ inability or reluctance to schedule visits at physical research locations. Decentralized approaches facilitate participation by a more diverse patient population and could ease COVID-19-imposed difficulties for both patients and clinical investigators.

“Now is the time to share ideas and insights that will chart the future course of clinical trials, accelerating drug development and saving lives – and by taking part in the DTRA, CenExel is demonstrating its leadership to drive change,” said Craig Lipset, DTRA co-convener, clinical innovation advisor, and a pioneer in decentralized trials. “We have a responsibility to advance the health of people with unmet medical needs, and by convening stakeholders from pharma companies, regulators, technology leaders and patient communities, we can remove remaining barriers to adoption and impact patients today.”

CenExel joins with its peer DTRA member organizations to provide expertise to identify and address gaps and needs and advance best practices through effective education and communication. CenExel urges other organizations interested in taking part to visit DTRA.org.

Media Contact: media@CenexelResearch.com

 

About DTRA
The Decentralized Trials & Research Alliance (DTRA) was convened to enable collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research. It works to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods.

About CenExel Clinical Research
CenExel Clinical Research (www.CenexelResearch.com) provides unparalleled medical and scientific support in the design and execution of clinical trials. Their attention to detail assures quality, reliable results and has helped CenExel to consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a great depth of experience and insight for the principal investigators and research staff in each facility. The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that clients achieve their clinical research goals.

 

 

Judith Montero, PsyD, Joins CenExel Clinical Research as Director of Clinical Assessments

Salt Lake City, Dec. 2, 2020 /PRNewswire/ — CenExel Clinical Research (“CenExel”) announced that Judith Montero, PsyD, has joined CenExel as Director of Clinical Assessments. Dr. Montero will work closely with rater personnel at all CenExel Centers of Excellence to ensure the highest quality of ratings scales and assessments are performed in psychiatric, pain, and neurology trials. Rater training plays a key role in minimizing placebo response in therapy studies and is a critical step in achieving successful trial outcomes.

Dr. Montero has a doctorate degree in clinical psychology from Albizu University Miami with concentration in neuropsychology. She completed her clinical neuropsychology doctoral internship at North Broward Medical Center in Pompano Beach. Prior to entering the pharmaceutical industry in 2002, she worked in a multidisciplinary clinical setting providing psychological services and conducting neuropsychological assessments to heterogeneous populations, including assisting with the diagnosis, development, and implementation of behavioral interventions for children and adults with various disorders.

With nearly 20 years in the clinical research industry, Dr. Montero has participated in numerous clinical trials as an investigator and rater, as well as developing inter-rater reliability programs and supervising rater teams. Formerly with Syneos Health, her comprehensive on-site experience was invaluable in her role as a Lead Clinical Scientist with the Clinical Surveillance & Training group.

Dr. Montero has developed rater training and data monitoring programs to deliver quality efficacy outcomes for psychiatric and neurologic studies in multiple indications, including Parkinson’s Disease, Spinal Muscular Atrophy (SMA), Autism Spectrum Disorder (ASD), Alzheimer’s Disease, schizophrenia and mood disorders. Dr. Montero is fully bilingual in English and Spanish with extensive experience administering clinical assessments and conducting training presentations in both languages.

“In certain therapeutic areas in clinical research, clear and unified rater assessments are absolutely essential to avoid ambiguity or errors,” noted Dr. Peter Ventre, founder and principal investigator at CenExel’s Research Centers of America (RCA). “Centralizing all our rater training and processes will strengthen CenExel’s CNS and pain research abilities, especially when sponsors take advantage of multiple CenExel Centers of Excellence on a specific study.”

“CenExel has built an excellent reputation in CNS research among its Centers of Excellence, with CBH Health, Atlanta Center for Medical Research (ACMR), and RCA. I am excited to have the opportunity to work closely with these sites and contribute to their proficiency and continuing success,” said Dr. Montero.

“We’re extremely pleased to offer Judy’s background and experience to our clinical research teams and to our clients,” said Tom Wardle, CEO of CenExel. “Her expertise complements and enhances our ongoing strategic efforts to further differentiate CenExel Centers of Excellence as the finest CNS research facilities in the United States.”

Media Contact: media@CenexelResearch.com

 

About CenExel Clinical Research
CenExel Clinical Research (www.CenexelResearch.com) provides unparalleled medical and scientific support in the design and execution of clinical trials. Their attention to detail assures quality, reliable results and has helped CenExel to consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a great depth of experience and insight for the principal investigators and research staff in each facility. The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that clients achieve their clinical research goals.

 

 

CenExel Offers Expert Presentations on Clinical Research Impacts of COVID-19

Prominent clinical research experts from CenExel’s Centers of Excellence have offered perspectives and insights on clinical trial impacts from COVID-19 via virtual presentations at the CNS Summit on October 30, 2020. Review the event recordings below.

Clinical Research in the Era of COVID-19: Patient, site, and sponsor perspectives
Presenters:
Dr. Elia Acevedo-Diaz, CBH Health
Dr. Peter Ventre, Research Centers of America
Dr. Corey Fowler, Otsuka

Stress and Coping with the COVID-19 Pandemic: A survey of psychiatric patients at clinical trial sites
Presenter: Dr. Robert Litman, CBH Health

Read more about CenExel’s experts featured at the CNS Summit 2020 event.

 

 

 

Stanford R. Plavin, MD, Joins Atlanta Center for Medical Research as Principal Investigator

Salt Lake City and Atlanta, Nov. 10, 2020 /PRNewswire/ — CenExel Clinical Research (“CenExel”) announced that Stanford R. Plavin, MD, DABA, has joined Atlanta Center for Medical Research (ACMR), a CenExel Center of Excellence, as a principal investigator for clinical studies in several therapeutic categories including acute pain and vaccines. Dr. Plavin’s expertise will expand clinical research capabilities at ACMR to outpatient surgical procedures where anesthesiology is required and help inform study design and protocol development.

Dr. Plavin, a Diplomate of the American Board of Anesthesiology (ABA), is owner and co-founder of Technical Anesthesia Strategies and Solutions LLC, a medical consulting and advisory firm, and founder of Ambulatory Anesthesia Partners LLC, an Atlanta-based physician practice. His continued operation of these practices will augment the ACMR network for recruiting study participants for several therapeutic areas, including acute pain.

Dr. Plavin received his Doctor of Medicine degree from the University of Vermont College of Medicine and completed his residency in anesthesiology at Emory University affiliated hospitals. He is licensed in medicine and surgery in multiple states, including Georgia and South Carolina. He has been an active speaker and lecturer at scientific meetings since 2011 and has published several peer-reviewed articles on surgery and anesthesia-related topics.

“I have functioned as a medical director and consultant to many outpatient surgical centers and large anesthesia practices and am very pleased to now be a part of ACMR,” said Dr. Plavin. “We are evaluating a new, reproducible acute pain model that is potentially less invasive and intrusive than the current standard, which should provide an advantage in conducting effective trials for pain therapeutics in the future.”

“With over twenty years of experience in the perioperative environment, Dr. Plavin will help ACMR facilitate the safe and appropriate delivery of any clinical trial requiring surgical or anesthetic intervention,” said Sarah Kazmi, MD, Vice President and General Manager of ACMR.

“We’re glad to add Dr. Plavin’s resources to our exceptional group of principal investigators,” said Tom Wardle, CEO of CenExel. “We are also excited that our ACMR site joins JBR Clinical Research – another of our Centers of Excellence – as the only two sites in the world selected to study a novel gene therapy in the treatment of lumbosacral radiculopathy, or sciatic nerve compression pain. Dr. Plavin’s experience will be instrumental in helping us to conduct that trial.”

Media Contact: media@CenexelResearch.com

 

About CenExel Clinical Research
CenExel Clinical Research (www.CenexelResearch.com) provides unparalleled medical and scientific support in the design and execution of clinical trials. Their attention to detail assures quality, reliable results and has helped CenExel to consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a great depth of experience and insight for the principal investigators and research staff in each facility. The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that clients achieve their clinical research goals.

About the Atlanta Center for Medical Research
ACMR (www.acmr.org) is a fully dedicated 100,000 square foot, state-of-the-art research facility. We provide conscientious, recruitment-driven medical research services that are pivotal in the advancement and treatment of illnesses of the central nervous system and other therapeutic areas. Our dedicated and experienced research teams conduct clinical trials with compassion and respect for our study participants. We are a CenExel Center of Excellence, assuring unparalleled patient engagement, staff expertise, and valuable results.

 

 

CenExel Experts Speak at CNS Summit 2020 on the Clinical Research Impacts of COVID-19

Salt Lake City, Oct. 27, 2020 /PRNewswire/ — Three prominent clinical research experts from CBH Health and Research Centers of America, both CenExel Clinical Research Centers of Excellence, will report perspectives and insights on clinical trial impacts from COVID-19 via virtual presentations at the CNS Summit 2020 on October 30, 2020.

Robert E. Litman, MD, Founder and Medical Director at CBH Health (Gaithersburg, MD), will participate in the Neuroscience Spotlight Session with a discussion of data in a presentation entitled, “Stress and Coping with the COVID-19 Pandemic: A Survey of Psychiatric Patients at Clinical Trial Sites.” Dr. Litman will cover disruptive aspects of the pandemic on psychiatric study populations and report on data analyzed from a survey of 94 trial patients diagnosed with bipolar disorder, major depressive disorder, or schizophrenia. The multi-site survey was conducted at CBH Health, Research Centers of America (Hollywood, FL), and Atlanta Center for Medical Research (Atlanta, GA) between June and September 2020.

A second Spotlight Session entitled “Clinical Research in the Era of COVID-19” will feature Elia Acevedo-Diaz, MD, Principal Investigator at CBH Health, and Peter Ventre, MD, Founder of Research Centers of America, in a presentation of patient and research site experiences and observations gathered during the COVID-19 pandemic. One topic will cover how research sites must adapt to maintain patient and employee safety and health, while preparing for potential emergencies. Corey Fowler, Ph.D., Director of Global Clinical Development at Otsuka America Pharmaceutical Inc., will offer the perspective and considerations of a study sponsor.

“Our experience demonstrates that CenExel Centers of Excellence can safely conduct clinical research in the era of COVID-19,” said Dr. Ventre. “We have implemented SOPs to address proper screening of volunteers and have adopted procedures to address the psychosocial needs of our study participants.”

“CenExel is pleased to contribute meaningful data and insights from our experience conducting clinical trials during this extremely challenging time,” said Tom Wardle, CEO of CenExel Clinical Research. “Since March 1, our network of five Centers of Excellence has supported more than 100 studies in over 20 therapeutic areas, screening more than 4,500 patients and enrolling over 3,200. We have seen fewer than 10 cases of COVID-19 among our patients and have implemented operating procedures immediately to protect patients and employees. Our practices and experience should benefit other clinical research facilities and pharmaceutical trial sponsors in reaching their study objectives.”

Both Spotlight Sessions will be offered concurrently through the CNS Summit virtual platform at 4:00 PM EDT on Friday, October 30, 2020. For more information on the CNS Summit 2020 registration, agenda and speakers, go to https://cnssummit.org

Media Contact: media@CenexelResearch.com

 

About CenExel Clinical Research
CenExel Clinical Research (www.CenexelResearch.com) provides unparalleled medical and scientific support in the design and execution of clinical trials. Their attention to detail assures quality, reliable results and has helped CenExel to consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a great depth of experience and insight for the principal investigators and research staff in each facility. The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that clients achieve their clinical research goals.

 

 

Experts at CenExel Clinical Research Sites Tackle COVID-19 Vaccine Testing

Salt Lake City, Sep. 2, 2020 /PRNewswire/ — CenExel Centers of Excellence are participating in U.S. Operation Warp Speed projects to advance COVID-19 vaccine research quickly without sacrificing quality. The Centers are already supporting seven ongoing trials for this novel coronavirus, beating recruiting targets by averaging more than 200 patients per week.

CenExel relied on internal expertise in expanding its capabilities within its network to offer world-class service in vaccine studies. Over the past several years, staff at CenExel’s Centers of Excellence have conducted over 100 vaccine trials across a wide spectrum of infectious and biodefense indications, enrolling well over 3,500 patients and surpassing recruitment goals by 110%.

“We understand the urgent nature of conducting these studies and reporting accurate results,” said Tom Wardle, CenExel CEO. “We take our role in helping to solve the COVID-19 healthcare crisis very seriously, and we’re laser-focused on the quality of our clinical research.”

CenExel’s five Centers average more than 25 years of professional experience in clinical research. Key principal investigators involved at the various facilities have worked on thousands of studies. Although the sites vary in size, they offer a collective 217,000 square feet of research space. With diverse metropolitan locations, the CenExel network has strong access to roughly 35 million people and well over a quarter million individuals within CenExel databases.

To speed up study implementation, CenExel provides centralized budgeting and contracting for sponsors engaging multiple Centers of Excellence. All Centers also adopted new pandemic standard operating procedures at the outset of this crisis and recently secured cutting-edge, rapid COVID-19 testing machines at each facility. These necessary precautions maintain safety for staff and patients across CenExel, as well as enable trials to proceed at the same pace as before, just with heightened standards.

To learn more about how to volunteer for a CenExel vaccine study, contact the Center of Excellence nearest you:

Media Contact: media@CenexelResearch.com

 

About CenExel Clinical Research
CenExel Clinical Research (www.CenexelResearch.com) provides unparalleled medical and scientific support in the design and execution of clinical trials. Their attention to detail assures quality, reliable results and has helped CenExel to consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a great depth of experience and insight for the principal investigators and research staff in each facility. The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that clients achieve their clinical research goals.

 

 

CenExel’s Research Centers of America Partners with Top Leadership to Fight COVID-19

MIAMI, Jul. 27, 2020 – Dr. Howard Schwartz, Chief Medical Officer and Principal Investigator for vaccine trials at Research Centers of America (RCA), a CenExel Center of Excellence, participated in a roundtable discussion today with U.S. Vice President Mike Pence, Florida Governor Ron DeSantis, Commissioner of the Food and Drug Administration Dr. Stephen Hahn, and other national, state, and local medical leaders.

Dr. Schwartz Joins VP Pence for Roundtable Discussion

The meeting launched the first phase III COVID-19 vaccine clinical trial, which was developed by Moderna, and which is an integral part of Operation Warp Speed. RCA will recruit between 300 to 500 patients for this study alone. RCA and other CenExel Centers of Excellence are concurrently recruiting for the other major national COVID-19 vaccine trials as well.

Governor DeSantis expressed encouragement in some improving numbers, citing decreased visits to emergency departments for COVID-like illnesses, lowered hospital admissions, and a “slowly but definitely declining” COVID test positivity rate. Without detracting from the optimistic atmosphere, Associate Professor of Clinical Medicine at the University of Miami Dr. Susanne Doblecki-Lewis noted that “Our goal here is to shape our volunteer population to really reflect the diversity of South Florida and the diversity of people who are affected by coronavirus. The only way to do that is to be in a place where there are ongoing infections.”

“Today is a day of hope,” Pence concluded. “Today is a day of promise. If all of us continue to do all we can, we’re going to reach the day when we put this coronavirus behind us.”

Learn more about RCA’s vaccine research or apply to participate in this COVID-19 study.