PRINCETON, N.J., May 25, 2011 /PRNewswire/ -- PharmaNet Development Group, Inc., a leading provider of clinical development services to pharmaceutical, biotechnology, generic drug and medical device companies, announced today that its subsidiary, PharmaNet Canada, Inc. (PharmaNet) and Maisonneuve-Rosemont Hospital (HMR) and its Research Center, one of the largest centers for nephrology in a single location in Canada, have agreed to collaborate in the conduct of 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 Under the current FDA draft guidance, certain of these studies require the evaluation of drug products in study participants that have impaired renal function.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.
"We are very pleased to partner with HMR," commented Riaz Bandali, President, Early Stage Development. "Demand for the conduct of pharmacokinetic studies in patients with impaired renal function is increasing. 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."
Mr. Bandali added, "We view this partnership with HMR as an important first step in PharmaNet's strategy to expand our academic expertise and the number of first-in-person and patient studies that we conduct in hospital settings."
"By partnering with PharmaNet, our renal impaired patients have the opportunity to contribute to the evaluation of innovative, potentially life-saving therapeutics in a safe environment with their own physicians," commented Dr. Vincent Pichette, Nephrologist-Pharmacologist and Director of the Nephrology Research, Maisonneuve-Rosemont Hospital.
Dr. Pichette added, "PharmaNet's professionalism and commitment to patient safety made them the partner of choice for the hospital. Our experience with them has been very positive."
PharmaNet Development Group, Inc., a recognized leader of global drug development services to the pharmaceutical, biotechnology, generic drug, and medical device industries, provides comprehensive capabilities in Phase I-IV clinical development, bioanalytical and bioequivalence services, regulatory, staffing, and therapeutic solutions. For the applied knowledge and intelligent solutions needed to accelerate drug development programs of all sizes around the world, PharmaNet works for you. For more information, please visit www.PharmaNet.com and www.pharmanetclinics.com.
The Maisonneuve-Rosemont Hospital Research Centre (CRHMR) is responsible for fulfilling the research mandate of the Hospital's mission. To achieve this, the Centre provides research investigators with an environment that is conducive to the advancement of scientific knowledge within the biomedical field. It also facilitates the transfer of technology into clinical practice as well as participates in training new research investigators and evaluating new technology. The Centre oversees the development of leading-edge research in areas that are closely connected to the clinical branches of excellence of the Maisonneuve-Rosemont Hospital: Immunology-oncology, Nephrology, Vision health. Additional information can be found at http://recherche.maisonneuve-rosemont.org/.
Affiliated with the University of Montreal, the Maisonneuve-Rosemont Hospital is a great institution where health care, education and medical research converge. Its 5,500 employees and physicians work for the population of greater Montreal and beyond, as the hospital has a supra-regional vocation. Three clinical areas stand out: eye health, hematology-oncology and nephrology. Each year, the hospital receives more than 4000 students, future doctors, nurses and health professionals. The Maisonneuve-Rosemont Hospital also houses a major research center.
The HMR hosts the second largest program of blood stem cell transplantation in Canada, realizing between 160 to 185 transplants annually. It is also one of the four most respected centers in North America. In 2008, the transplant program received the (FACT) accreditation, from the Foundation for Accreditation of Cellular Therapy, which certifies the level of quality recognized worldwide with regards to the handling of stem cells and patient care. Recently, the Ministry of Health and Social Services (MHSS) Directorate for the fight against cancer awarded the HMR a level 4, the highest standard of excellence for health plan.
SOURCE PharmaNet Development Group, Inc.