Michael A. Schwarzschild, MD PhD Chair, Parkinson Study Group (PSG) Executive Committee
“The CMSU has brought deep experience and commitment and delivered exceptional service to our Parkinson’s disease trials for years. In our most recent project, their knowledgeable staff expertly guided and managed all aspects of drug supply for a 57-site North American phase 3 trial. At the outset of the project they navigated a complex, three-continent manufacturing and supply chain from raw material to clinical trial material – rigorously matching placebo and active study drug, and oversaw development and execution of a demanding drug life cycle spanning manufacturing, stability testing, packaging, site supply and inventory, as well as secondary drug pharmacy needs. As challenges arose during API QC, transport, manufacturing and stability testing, their immediate responsiveness and technical skill averted delays or worse on several occasions. Thanks to the quality of their work and despite those challenges, we met all our drug supply milestones and goals. I highly and unreservedly recommend their services.”
Laura Linscott, Director of Quality Assurance, SIGA Technologies, Inc.
"Over the past four years, the CMSU has supported seven of our clinical studies, with several more currently in the planning stages. We had a great experience with each one. The CMSU team is friendly, responsive, flexible, and thorough. Additionally, the CMSU quality team has a strong quality system in place ensuring GMP compliance with any project we’ve asked them to perform in support of our clinical program."
Debra M. Foster, B.Sc. Vice President, Clinical Development Spectral Medical, Inc.
"Good clinical practice as delineated in the ICH (E6) R(2) section 5.14 declares that Sponsors of Clinical trials are responsible for the Supplying and Handling of Investigational Products. For a small biotech company running a phase 3 clinical trial, such as ourselves, we needed a reliable third party who could manage this task as our partner. Pat Bolger and the excellent crew at CMSU filled that role at a very high level and at all times displayed professionalism and responsiveness to the study sites and Sponsor’s needs. It was a very complicated study protocol. Yet, our affable working partnership continued through 5+ years of the study period. I highly recommend the CMSU for your Clinical Services materials needs! VP Clinical Development Biotech Company."
Tacey X. Viegas, Ph.D., Chief Operating Officer, Serina Therapeutics, Inc.
"As a small pharmaceutical company developing a novel product pipeline to treat Parkinson’s Disease, we needed a small but focused contract establishment to act as our clinical supply partner to handle and distribute our drug product to different clinical sites. Patrick Bolger, Joan Woodcook and the Clinical Materials Service Unit (CMSU) team stepped in and prepared the labels, patient dosing kits and shippers for us. They monitored storage, distribution and returns during the entire study. They were professional and very thorough to ensure GMP compliance. I highly recommend CMSU for your Clinical Services requirements!"
Tanya Simuni, MD Arthur C. Nielsen Professor of Neurology Director, Parkinson's disease and Movement Disorders Center Northwestern University Feinberg School of Medicine
"Reflecting on our collaboration for close to 10 years, I want to provide the highest level of accolades to CMSU staff and their services. They have been not only reliable and professional partners, but valuable collaborators in the studies design and grants submissions. They have supported our Phase II and III studies from inception to the close out process effectively navigating through the maze of all GMP/GCP requirements, communications with the regulators and the sites. I highly and enthusiastically recommend their team!"