“CorDynamics has developed a high-quality safety pharmacology program backed by their world-class reputation in cardiovascular discovery and screening services. The addition of this GLP safety pharmacology program to Sinclair’s growing nonclinical toxicology services is an excellent strategic fit and enables us to support critical IND-enabling programs at a single research site,” Sinclair Research vice president of commercial operations Andy Brown said. “Sinclair Research will be able to provide in vivo safety pharmacology studies, standalone or as part of an IND-enabling package, to help pharmaceutical developers assess the potential for adverse effects prior to first-in-human trials. We’re excited to offer non-GLP screening studies and GLP core battery studies in the future.”
In addition to being able to support safety pharmacology core battery assessments of cardiovascular, respiratory and central nervous systems as outlined in ICH S7A guidelines, Sinclair’s strategic partnership with CorDynamics brings many years of expertise in studying primary and secondary pharmacodynamic effects in vital organ systems, for a wide range of test materials, in multiple preclinical species.
“The CorDynamics team is excited about transitioning our GLP safety pharmacology services to a capable partner in Sinclair Research, allowing us to focus on our earlier stage drug discovery and compound screening models along with troubleshooting complex cardiovascular issues,” CorDynamics founder and chief executive officer Dr. Michael R. Gralinski said. “Our team will assist Sinclair Research with critical setup and equipment validation to ensure a smooth transition of study management for our existing clients and the same high-quality service for future customers.”
About Sinclair Research
Sinclair Research, a nonclinical contract research organization (CRO), offers animal efficacy models, pharmacokinetics/pharmacodynamics evaluation, and IND-enabling toxicology and safety pharmacology research capabilities to support biopharmaceutical, animal health and medical device development programs. Sinclair is experienced in all research models and is the leading expert in miniature swine research. Built on more than 50 years of experience, Sinclair has emerged as a leader in diabetes, dermal, otic and animal health research services with streamlined quality systems supporting both VICH and GLP-compliant studies and SEND reporting with no backlog.
Founded in 2002, CorDynamics is the premier preclinical cardiovascular contract research organization (CRO) and consulting group focused on examining the cardiovascular effects of emerging drug candidates. The company is an industry leader in cardiovascular research and provides expertise, analysis and support with discovery and drug safety studies for more than 500 international biopharmaceutical clients.
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