Trial-CARE is a highly flexible unit that can configure itself to serve study teams in a variety of roles and capacities, offering targeted expertise and work effort to complement the investigator’s research team. Some examples of advanced clinical trial management functions enabled by Trial-CARE in a limited support capacity are noted here and include but are not limited to Executive Secretary (ES) services, Data Safety and Monitoring (DSM) Plan development and management, quality monitoring, compliance to the FDA’s 21 CFR Part 11 regulations.
Examples of our targeted support services for client projects are listed below.
A Randomized Unblinded Feasibility Study Evaluating the Use of Oral Administration of MB-102 versus Dual Sugar Testing for Gut Permeability in Normal Subjects and Subjects with Active Small Bowel Crohn’s Disease.
PI: Dr. Lori Holtz, MD, Associate Professor, Department of Pediatrics
CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONA virus prevention.
PI: Michael Avidan, MBBCh, FCA, SA; Dr. Seymour and Rose T. Brown Professor of Anesthesiology; Head of the Department of Anesthesiology
Effect of a Dual Orexin Receptor Antagonist on CSF Alzheimer’s Disease Biomarkers (DORA and LP)
PI: Dr. Brendan Lucey, MD, Professor, Department of Neurology and Section Chief of Sleep Medicine
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis with 64Cu-25%-CANF-Comb II
PI: Pamela K. Woodard, M.D., Chair Department of Radiology, Elizabeth E. Mallinckrodt Professor of Radiology, Director, Mallinckrodt Institute of Radiology, Professor of Biomedical Engineering, and Head of Advanced Cardiac Imaging (CT/MR)
Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment (PINIHL-AET)
PI. Craig Buchman, MD, Lindburg Professor and Chair of Department of Otolaryngology – Head & Neck Surgery
Significance of Spinal Movement Impairments in Acute Low Back Pain (LBP)
PI: Dr. Linda Van Dillen, P.T., Ph.D., Professor of Physical Therapy and Orthopedic Surgery and Division Director of Research