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FDA approves Shire’s FIRAZYR for acute attacks of hereditary angioedema
Shire plc announced that the US Food and Drug Administration (FDA) has granted marketing approval for FIRAZYR (icatibant injection) for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. “Until now, HA…
edit | 25 August 2011
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PPD Earns CAP Accreditation in Singapore
PPD has announced that its global central lab operations in Singapore has earned accreditation by the College of American Pathologists (CAP). This validates its ability to deliver high-quality, reliable data that meet standards of excellence in e…
edit | 10 February 2010
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SCDM Releases Best Practices for Automated Data Cleaning
The Society for Clinical Data Management (SCDM) has published Edit Check Design Principles, a collection of best practices for the creation of edit checks – a key tool for efficiency and data quality. The chapter is an addition to SCDM’s Good …
edit | 21 January 2010
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Maccine Receives GLP Accreditation from SPRING Singapore
Maccine has been formally acknowledged by SPRING Singapore as Good Laboratory Practice (GLP)-compliant. Leigh Berryman, CEO of Maccine, comments, “Maccine is a fully GLP-compliant, internationally recognized Contract Research Organization (CRO)…
edit | 04 November 2009
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Proteomics International Receives ISO Accreditation
Proteomics International has been awarded accreditation under ISO 17025 by Australia’s accreditation agency, National Association of Testing Authorities (NATA). This accreditation is the first time globally that a proteomics service laboratory has …
edit | 03 September 2009
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Sundia Speeds Up Customs Clearance in China
Since the implementation of Express Customs Clearance on a trial basis for Sundia MediTech in Zhangjiang Hi-Tech Park in Shanghai, the customs clearance time for the company’s Contract Research Organization (CRO) shipments has been shortened from t…
edit | 13 August 2009
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Quotient Clinical Receives MHRA Accreditation
Quotient Clinical has been awarded Supplementary Accreditation from the Medicines and Healthcare products Regulatory Agency (MHRA). This confirms that the company is qualified to perform the full range of Phase I trials, including First-in-Human (FIH…
edit | 01 August 2009
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Pfizer: Accredited for Human Rights Protection In Clinical Research
Pfizer has announced that it is the first pharmaceutical company to be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) for ensuring the protection of human subjects taking part in early-stage clinica…
edit | 16 April 2009
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JALA Editorial Board Appoints Eight Members
The Association for Laboratory Automation (ALA), has announced eight additions to its Journal of the Association for Laboratory Automation (JALA) editorial board. They include: • Eiji Osawa, Ph D, president and professor emeritus at NanoCarbo…
edit | 13 March 2009
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Managing Clinical Trials with 3G Technology
Consider the freedom and flexibility mobile phone technologies can bring for operators and subjects in a clinical trial: round-the-clock access to contacts, communication of real-time information, reporting of drug reactions and symptoms, and ob…
edit | 01 October 2008
