Applied Clinical Trials-10-11-2005

From The Pressroom
Applied Clinical Trials

October 11, 2005

The New England Journal of Medicine published the results from a National Institute of Mental Health-funded study titled Clinical Antipsychotic Trial of Intervention Effectiveness – Schizophrenia (CATIE–SZ). ICTI is proud to reveal that the data for this study, conducted with 1493 subjects from 57 clinical sites in 24 states, was collected using an early version of ICTI’s iTrial EDC software.

The pace of industry consolidation shows no signs of slowing down, and more mergers seem inevitable. Who will be the biggest players in another 10 years? Which companies look set to be swallowed up? A leading pharmaceutical analyst and former investment banker made his predictions at the Networking Dinner of the ACT European Summit.

Medidata Chief Medical Officer Ed Ikeguchi to Discuss Future of Clinical Trial Technology and Deliver Hands-On EDC Training with Medidata’s Rave 5.4 platform

Applied Clinical Trials
Seen and Heard

October 10, 2005

A pictorial walk through the Applied Clinical Trials European Summit

Andy Richardson, Zenetar Ltd; Case Study: Use of EDC at Boehringer Ingelheim, Stephane Collet, Boeringer Ingelheim, Andrew Cooper, Oracle Corp.;

Meeting News
Applied Clinical Trials

October 10, 2005

News broke last week about the initial success of Merck & Co's experimental vaccine to prevent cervical cancer. Gardasil, a genetically engineered vaccine, blocks infection with two types of human papilloma virus, HPV 16 and 18. This development added to the mood of excitement and air of eager anticipation surrounding the 75-minute workshop given by a leading European expert in vaccine trials.

eResearchTechnology, Inc. (eRT) (Nasdaq: ERES - News), a leading provider of centralized electrocardiographic (ECG) services and e-research technology and services, announced today that it has signed approximately $32 million in third quarter contracts setting a new record for quarterly signings, capped by two late phase program awards from two Top 15 global pharmaceuticals awarded at month end.

Meeting News
Applied Clinical Trials

October 10, 2005

All is not well in the world of drug safety, it seems. Speakers and delegates expressed serious concerns about the European Union's new pharmacovigilance system. It is creating a huge bureaucratic burden for ethics committees and investigators, important differences exist between each country's interpretation and implementation of the regulations, and uncertainty surrounds the precise responsibilities of each partner in the clinical trial process.

Welcome
Applied Clinical Trials

October 10, 2005

Welcome to the 12th Annual Applied Clinical Trials European Summit E-Show Daily presented by ACT magazine. This special show daily is designed to give you a recap and highlights of the seminar proceedings and plenary sessions from the conference floor. The conference covered the regulatory climate in Europe and electronic data capture.

etrials Worldwide, Inc., the first company to offer fully integrated, easy-to-use eClinical software for the clinical trial process, today announced that it has added three new studies for top ten pharmaceutical companies. All three trials will use etrials' electronic patient diary technology on handheld devices (PDAs) to electronically capture patient reported outcomes (ePRO).

Meeting News
Applied Clinical Trials

October 10, 2005

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.

Meeting News
Applied Clinical Trials

October 10, 2005

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.

Applied Clinical Trials

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