Synomics Pharma and BioScience Laboratories, Inc. announced a formal partnership to provide fully integrated topical clinical phase 1 study services for trials in healthy human subjects, providing drug developers with a single source for outsourcing clinical trials.
Wareham, MA (PRWEB) January 13, 2010 -- Synomics Pharma and BioScience Laboratories, Inc. announced a formal partnership to provide fully integrated topical clinical phase 1 study services for trials in healthy human subjects, providing drug developers with a single source for outsourcing clinical trials.
Synomics Pharma’s reliable preclinical and clinical bioanalysis and analytical chemistry services, combined with BioScience Laboratories’ 18 years of experience conducting clinical trials, provides drug developers with a comprehensive outsourcing solution for topical clinical phase 1 study needs in a GCP and GLP compliant environment.
As the need for improved quality of data from clinical trials rises, drug developers are increasingly turning to United States-based contract research organizations (CROs). To ensure regulatory acceptance, pharmaceutical developers are requiring that clinical trials be conducted in strict compliance with the FDA, GCP, and GLP guidelines. For drug developers trying to bring a product to market while adhering to stringent timelines, selecting a CRO capable of conducting the clinical trial on time, on budget, and with resulting data suitable for FDA submission is critical. The partnership between Synomics Pharma and BioScience Laboratories enables an efficient single point of project management, with a full array of bioanalytical and topical clinical trial capabilities.
“Our significant experience in conducting clinical trials, combined with Synomics Pharma’s robust quality system, responsive team, and state-of-the-art bioanalysis techniques, creates an exceptional resource for outsourcing phase 1 clinical trials,” said Daryl Paulson, Ph.D., Chief Executive Officer of BioScience Laboratories.
“Synomics Pharma’s comprehensive quality management system reduces regulatory risk,” said John Pirro, Vice President and Chief Operating Officer of Synomics Pharma. “Our active involvement with the Bioanalytical Quality Standards Initiative (BQSI) for the implementation of ICH Q10 for clinical trials demonstrates our commitment to consistency and quality in clinical bioanalysis. The alliance between Synomics Pharma and BioScience Laboratories produces a versatile topical clinical phase 1 study service offering that will be highly beneficial to the industry.”
A white paper from Synomics Pharma, titled “BioAnalytical Quality Standard Initiative — Implementing ICH Q10 for Clinical Trials”, describes the BQSI, an initiative born out of the industry-wide recognition that neither the US FDA or EMEA regulation nor ICH harmonized guidelines address laboratory analysis in support of clinical trials. To download the white paper, visit http://info.synomicspharma.com/bqsi/.
Synomics Pharmaceutical Services, LLC, a global Contract Research Organization (CRO), specializes in customized preclinical and clinical bioanalytical services, stability studies, and analytical chemistry services for the pharmaceutical industry for the pharmaceutical, personal care, and allied industries. Synomics Pharma, a Smithers Group company, provides a broad portfolio of services in support of drug development and production, and its FDA-inspected quality management system is globally recognized by authorities as an industry benchmark. Smithers Group member company, SP Formulations, provides drug formulation development services in a variety of pharmaceutical dosage forms including parenterals, liquids, and semi-solids.
BioScience Laboratories, Inc. was founded in 1991 in Bozeman, MT, to provide antimicrobial product testing and result interpretation grounded in science. Today, BioScience Laboratories offers a variety of state-of-the-art laboratory services and guidance regarding federal regulatory agency requirements for the healthcare, pharmaceutical, personal care and consumer products markets.
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