Navigation Links
Synomics Pharma and Bioscience Laboratories Announce Partnership to Provide Topical Clinical Phase 1 Study Services
Date:1/13/2010

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.

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.

###

Read the full story at http://www.prweb.com/releases/2010/01/prweb3439734.htm.


'/>"/>
Source: PRWeb
Copyright©2010 Vocus, Inc.
All rights reserved  

Related medicine news :

1. Microbix and Therapure Biopharma Form Partnership to Expand Water-Based Supplies to the Pharma Industry
2. Genetix Pharmaceuticals' Adrenoleukodystrophy (ALD) Product Recognized As One of Science Magazine's Top 10 Scientific Breakthroughs of 2009
3. Keenan Offers New Pharmacy Discount Card Program with No Eligibility Requirements and No Cost to User
4. Penn Pharma Invests In World-Class Inventory Management System
5. Seven More Biopharmaceutical Research Companies Join PhRMA
6. CVS/pharmacy and MinuteClinic to Provide H1N1 Vaccines in 8 New States
7. PharmaSmart International, Inc and AstraZeneca Canada Enter Into Strategic Partnership to Elevate Pharmacy Based Hypertension Management
8. Pharmacists improve care of diabetics while cutting costs, UB research shows
9. 5,000 Web Sites Selling Prescription Drugs Outside of Pharmacy Laws and Practice Standards
10. Cardiome Pharma Corp. Permitting Automatic Securities Disposition and Purchase Plans
11. CVS/pharmacy and MinuteClinic Now Providing H1N1 Vaccinations in Arizona
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Synomics Pharma and Bioscience Laboratories Announce Partnership to Provide Topical Clinical Phase 1 Study Services 
(Date:4/29/2016)... ... April 29, 2016 , ... For those who skip meals occasionally ... miss. That was among the many new lifestyle diet tips offered by nutritionists Pam ... Hour® Power of Water® radio show. Bonny and Lawrence noted that because proper nutrition, ...
(Date:4/29/2016)... ... ... Regenerative Medicine Solutions (RMS) scored 94.8124 out of 100 on Tampa ... for Tampa’s Best Places to Work. They were ranked in the Big Category, which ... our team,” says RMS Human Resources Manager Irene Miller. “We work hard to build ...
(Date:4/29/2016)... ... 2016 , ... Nike Softball Camp at the College of Brockport in New ... girls aged 10-18. All facets of the game will be covered; hitting, fielding, base-running, ... one of the finest softball facilities in the region. The outstanding professional college staff ...
(Date:4/29/2016)... ... April 29, 2016 , ... HEALTHCAREfirst , ... coding services, and Deyta Analytics, recently announced the recipients of the fourth annual ... quality as measured from the caregiver’s point of view. The official list of ...
(Date:4/29/2016)... ... 2016 , ... Intellitec Solutions will be a sponsor at ... the Broward County Convention Center. The event is a chance for finance professionals ... public facility management. Intellitec Solutions will highlight their customized accounting solutions designed for ...
Breaking Medicine News(10 mins):
(Date:4/27/2016)... 2016  Hologic, Inc. (Nasdaq: HOLX ... the fiscal second quarter ended March 26, 2016.  ... increased 41.2%, and non-GAAP diluted EPS of $0.47 ... on a reported basis, and 6.3% on a ... another good quarter, highlighted by 14.6% growth in ...
(Date:4/27/2016)... Transparency Market Research has published ... Global Industry Analysis, Size, Share, Growth, Trends, and Forecast ... skincare devices market was valued at US$ 7,255.8 Mn ... CAGR of 10.1% from 2015 to 2023 to reach ... full Skincare Devices Market (Treatment Device - LED Therapy Devices, ...
(Date:4/27/2016)... April 27, 2016 ... the  "Global Anesthesia Disposables Market 2016-2020"  report ... ) ,The global anesthesia disposables market ... of 4.03% during the period 2016-2020.  ... threat to patients, safety. Organizations like the ...
Breaking Medicine Technology: