PharmaNet Development Group, a provider of clinical development services to pharmaceutical, biotechnology, generic drug and medical device companies, announced that its subsidiary, PharmaNet Canada, and Maisonneuve-Rosemont Hospital (HMR) and its research center, will collaborate to conduct pharmacokinetic studies in patients with impaired renal function.
At PharmaNet's clinical pharmacology unit in Canada, new drugs are evaluated in phase I clinical studies for PharmaNet's clients. Under the current FDA draft guidance, certain of these studies require the evaluation of drug products in study participants that have impaired renal function. The collaboration with HMR will provide PharmaNet enhanced access to potential study participants with mild, moderate, or severe impaired renal function.
By partnering with HMR, a leading nephrology center and specialized hospital, we can efficiently conduct trials in patients with various levels of renal impairment, while assuring the patients' safety and well-being," commented Riaz Bandali, president of early stage development at PharmaNet.