Salt Lake City, Utah, Nov. 15, 2022 (GLOBE NEWSWIRE) -- CenExel announces a new Clinical Sciences business unit, composed of early phase and translational medicine scientists, plus the broader network of CenExel therapeutic experts and key opinion leaders (KOLs), providing support to all the CenExel Centers of Excellence as well as standalone consulting services. Clinical Sciences by CenExel (Clinical Sciences) offers a unique opportunity for collaboration with pharmaceutical sponsors, CROs, and vendors, to support study development and conduct within the Sponsor’s clinical development program across the development lifecycle. These activities include Clinical Sciences support from pre-Investigational-New-Drug (pre-IND), Phase I, and translational medicine studies through to Phase III pivotal studies, peri-approval, and Phase IV studies. Clinical Sciences can provide scientific consulting for clinical development planning, study design, recruitment solutions, dose selection criteria to support more confident go/no-go decisions through the application of fit-for-purpose biomarkers, measures, and endpoints. CenExel’s leadership in the design and conduct of ethnic sensitivity and bridging studies enables global product development. All told, these elements combine in Clinical Sciences to create a unique, first-of-its-kind, holistic approach in the clinical research industry.
The Clinical Sciences team is led by Doctors Larry Ereshefsky, Robert Litman, and Brett English. Larry Ereshefsky, PharmD, BCPP, will serve as Chief Scientific Officer – Early Phase, while Robert Litman, MD, will serve as Chief Scientific Officer – Psychiatry. Brett English, PharmD, PhD, will serve as Vice President in the division.
Clinical Sciences by CenExel offers unprecedented expertise and experience in study design strategies including complex biomarker studies that can inform key go/no-go decisions. CenExel has already leveraged the National Institute of Mental Health’s (NIMH’s) Research Domain Criteria (RDoC) approach with many novel molecules, working directly with Sponsors and various academic KOLs in adapting novel paradigms utilizing both electrophysiology and neuroimaging. Doctors Ereshefsky and English are innovators in the application of translational drug development tools, adept at integrating state-of-the-art technologies within a single study for corroborative and correlative analyses.
For later Phase II and III studies, Clinical Sciences by CenExel provides real-world experience and consultation for sponsors to design protocols with feasibility characteristics that maximize recruitment and retention of high-quality research subjects while meeting sponsor's scientific objectives. This is accomplished by leveraging the experience and know-how of CenExel’s formidable group of PIs, clinical managers, and therapeutic area thought leaders overseen by Dr. Robert E. Litman, an NIH-trained, experienced clinical trialist and researcher. Dr. Litman joins Doctors Ereshefsky and English in supporting the scale up and integration of lessons learned from early-phase studies, extending biomarker/translational endpoints into the design and execution of later phase clinical trials which can be conducted at CenExel’s centers of excellence.
In addition to in-house scientists, Clinical Sciences also includes a CenExel Scientific Advisory Board, whose primary function is to provide independent clinical and scientific guidance in areas requiring specific therapeutic expertise such as neuroimaging, cognitive and behavioral measures, psychedelics, and new technologies.
“We enjoy a long history of collaboration with vendors and external key opinion leaders who support our turnkey strategies for neuroimaging data acquisition and analysis, as well as EEG-/ERP-related endpoint selection, collection, and analysis,” said Dr. Larry Ereshefsky, “We also continuously refine processes to ensure safe and efficient first-in-human trials.”
“We look forward to continuing to work directly with clinical teams at the CenExel Centers of Excellence, providing guidance and training,” said Dr. Brett English, “We’re committed to harmonizing the scientific, technological, and clinical processes across the whole site network.”
“Our extensive experience spans a wide variety of study objectives and designs,” said Dr. Robert Litman, “We know the intricacies of working on every phase of a trial, including ensuring quality ratings data, facilitating recruitment, and selecting the right patient for trial inclusion.”
CenExel was formed in 2018, and since its formation has strategically invested to support organic growth in its Centers of Excellence while also pursuing acquisitions of state-of-the-art research centers across the U.S. The mission of CenExel is to work with trial Sponsors and CROs to drive efficiencies in clinical research while reducing the costs and development timelines for innovative therapies to advance patient care.
About CenExel
CenExel (www.CenExel.com) provides unparalleled medical and scientific support in the design and execution of clinical trials. Our therapeutic area focus, attention to detail, and auxiliary services assure quality, reliable results and help CenExel 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 vast 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 their clients achieve their clinical research goals.
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