CMSU In The News
CMSU In The News
- The University of Rochester Medicine’s Clinical Materials Services Unit (CMSU) announces the unit’s partnership with the Keck School of Medicine of the University of Southern California (USC) for two National Institutes of Health (NIH)-funded platform clinical trials: the Alzheimer’s Tau Platform (ATP) Clinical Trial (NIH Grant #: R01AG078457) and the Progressive Supranuclear Palsy Clinical Trial Platform (PTP) (NIH Grant #: R01AG085029). The Keck School of Medicine will act as the Clinical Coordinating Center for both trials, while CMSU will serve as the Central Pharmacy Depot, receiving active drugs and placebos (IP), processing and blinding each, and sending them to investigative sites for dispensation to participants.
- NIH Taps URMC to Help Develop New Pain Relievers to Combat Opioid Crisis - "The Medical Center’s Clinical Materials Services Unit, which is part of the Center for Health + Technology and led by senior research associate Cornelia Kamp, M.B.A., will also provide support to the CCC by providing clinical supply chain management, packaging, labeling, distribution, and return services of drugs and devices used in EPICC-Net clinical studies."
- CMSU Tapped for ALS Clinical Trial Initiative - The Clinical Materials Services Unit (CMSU) has been awarded the contract to provide drug supply and distribution services to the for a new clinical research initiative that seeks to rapidly evaluate new drug candidates for Amyotrophic Lateral Sclerosis (ALS).
News You Can Use
- New Rules for European Investigational Medicines - Gaps in the good manufacturing practice controls on medicines for clinical trials are targeted in new rules from the EU
- Diversity in Clinical Trials: Path to Achieving Health Equity - "How can we, as individual members of the clinical research community, take steps toward achieving the cultural competence that leads to diversity in clinical trials?"
- Succeeding With OOS and Root-Cause Investigations
- FDA Publishes Guidance On CGMP Requirements during COVID-19
- Sharing Best Practices for Successful Clinical Trials
- Getting To The Root Of Quality Problems
- Overcoming Transportation Barriers to Trial Participation
- Retention Strategies For Keeping Participants Engaged
- FDA Analysis of Top Drug GMP Inspection Citations in FY2018
- Labeling Challenges from EU Annex
- Quality Risk Management Plans Create Effective Quality Systems
- Growth in Rare Disease R&D Challenging Development Strategy and Execution
- A New Approach to Temperature Monitoring in A Changing Clinical Supply Chain Management
- Michael J. Fox Foundation and 23andMe Launch Fox DEN
- Virtual Clinical Trials, The Future Of Patient Engagement
- Clinical Trial Supply and Logistics
- Risk Based Monitoring
- How Drugs are Approved: An Insider’s Look at the FDA
- FDA's Latest Data Integrity Guidance
- FDA Publishes Latest Guideline On Orphan Drug Development
- Possible Parkinson's 'Pandemic' Looms (US News Article Featuring University of Rochester's Dr. Ray Dorsey)
- Revisions To Informed Consent Regulations?
- University Of Iowa Pharmaceuticals, CMSU's Partner In Providing High Quality Investigational Products
Study Groups
- Parkinson Study Group
- Huntington Study Group
- National Institute for Pharmaceutical Technology and Education (NIPTE)
- NeuroNEXT
Within the University of Rochester
- Clinical Trials Coordination Center
- University of Rochester Center For Health + Technology (CHeT)
- University of Rochester Office of Human Subject Protection
- URMC Central Laboratory Services
- Clinical Translational Science Institute