News

Presenters included Jean-Pierre Isal, Consultant, UK; Jean-Marc Husson, Prof, Eur Acad of Pharm Med, France; Astra Zeneca. The system has been changed from the Notification System, established in 1988 to a formal Clinical Trial Authorization, 2004-5.

It's more than 20 years since outsourcing was used in the pharma industry, but the phenomenon remains as popular as ever. Sponsors continue to invest heavily in product development, but they are spending less and less on internal support staff. India is proving an increasingly attractive location for clinical research organizers.

etrials Worldwide, Inc., the first company to offer fully integrated, easy-to-use eClinical software for the clinical trial process, and CEA Acquisition Corporation (CEAC.OB), a special purpose acquisition corporation, announced today an agreement to merge the two companies. After completion of the merger, etrials Worldwide will be a wholly owned subsidiary of CEAC and etrials shareholders will own a majority interest in the parent company CEAC, a public reporting company.

Stephen Senn, Prof Statistics, Univ of Glasgow, Willi Maurer, Global Head Statistical Methodology, Novartis

Diosynth Biotechnology to Manufacture Antibody for ImmunoGen

The presentation, entitled, "Two ONCONASE® Clinical Trials in MM Patients Evaluated Using the EORTC Prognostic Model," will analyze whether there is a difference in survival between ONCONASE study patients categorized as 'Good' or 'Poor' risk for survival, using European Organization for the Research and Treatment of Cancer (EORTC) prognostic scores.

Tools for Clinical Trials Professionals

Empowering Consumers to Learn More and Make Informed Decisions is Goal

FDA Commissioner resigns just months after taking on the position.

Biopharmaceutical firm expands usage of Prism® to additional studies to facilitate real-time data capture and analysis

Javelin Pharmaceuticals, Inc. (OTC BB: JVPH) has named Curtis Wright, IV, MD, MPH as Vice President of Risk Management and Regulatory Affairs.

Quicker approval of new drugs by the U.S. Food and Drug Administration (FDA) has not increased the number of prescription drugs withdrawn for safety reasons in this country, according to an analysis recently completed by the Tufts Center for the Study of Drug Development.

Immusol will characterize the biological activity of such ingredients using its proprietary assays for oncology, infectious disease, and other disease areas.

Toby Jane Hindin, EdD, M.Ed. MS

The new 3-year manufacturing and supply agreement is effective as of January 1, 2005.

Targeted Replacement Therapy for Growth Failure in Children With Low Blood Levels of the Hormone IGF-1

Galt Associates (Sterling, VA) has brought together the original Halo web-based safety research and monitoring environment with its dsNavigator search engine for a new and improved Halo platform. Featuring streamlined yet powerful querying capabilities, the platform offers ready access to a vast array of information sources-including FDA and WHO datasets-while a sophisticated interface gives safety professionals automated tools and an intuitive way to manage and analyze data.

Thoughtful application of eDiaries can make clinical development much more efficient.

This newly updated reference guide addresses the most difficult, emerging, and frequently asked GCP questions today.

Acquisition Significantly Expands Clinical Trial Material Supply Capabilities and Customer Support, Jumps Aptuit to Largest Global Provider by Capacity

Eisai's decision is based on Phase II study results that showed a reduction in mortality in eritoran-treated patients versus placebo.

PAREXEL International Corporation (Nasdaq: PRXL) today announced that on August 22, 2005 it acquired all of the shares held by minority stockholders of Perceptive Informatics, Inc., its information technology subsidiary, and now owns all of the outstanding common stock of Perceptive.

Clinical Supplies Management Inc. (CSM) in Fargo, North Dakota has established a cross-continent relationship with leading UK outsource services provider Brecon Pharmaceuticals Ltd.

Covance Inc. (NYSE: CVD http://rd.bcentral.com/?ID=3182929&s=81101478) added to its Phase I capacity and further enhanced its reputation for clinical excellence with the purchase today of GFI Clinical Services from West Pharmaceutical Services, Inc. (NYSE: WST).

Three new customers, including Morphotek Inc., Vitae Pharmaceuticals, Inc. and a medical device subsidiary of a top pharmaceutical conglomerate, signed agreements in July with Phoenix Data Systems to use the company's electronic data capture solutions.

Company Enters Funding Transaction to Support Acquisition Strategy and International Growth.

Dedicated Business Unit Responds to Unmet Need

The Taipei, Taiwan-headquartered biotechnology and pharmaceutical company is now looking for international licensing partners to take the herbal-based product on to further clinical trials and subsequent commercialization.