News

Group to audit pain trials for design flaws

Researchers are investigating the trouble with pain studies. They hope to identify problems in design and implementation to help explain why many of pain trials fail, yielding no meaningful

Biolex gives Unithink e-PRO a trial role

An electronic patient-reported outcome system has played a key role in a Phase II trial. The trial yielded positive results for a hepatitis C treatment from Biolex Therapeutics. During the trial,

Solutions streamline, rate AE reports

Pegasystems has unveiled an adverse event case processing solution for collecting, managing and analyzing adverse events during and after clinical trials. Meanwhile, Quantros has introduced a

FDA contracts for Internet support, analytics

The FDA has signed a $53 million contract with IT service provider GlobalNet Services. The five-year deal covers Internet support and hosting services. GlobalNet will provide content management, site

Site provides trial matches, forum for diabetics

Start-up Corengi (for clinical options research engine) has put its own Web 2.0 spin on subject recruitment. It's developed a site that provides a 20-question survey to help potential subjects narrow

FDA creates IT shopping list for makeover

The FDA is thinking big. Under its regulatory science initiative, it's looking for high-horsepower data mining and scientific computing capabilities. It wants to use these tools during drug reviews

HHS counts 200 data breaches

The U.S. Department of Health and Human Services counts nearly 200 health information data breaches of records for 500 or more individuals. The breaches often occur at "highly respected and

EDC gets cool reception in the clinic

Here's a zinger: Using electronic data capture technology has driven up the cost of clinical trials. That's according to Tal Zaks, VP for oncology development at Sanofi-Aventis. He's someone who

Ovum analyst sees analytics boost in Oracle CDA 2.0

Oracle's CDA 2.0, the clinical data analytics system upgrade unveiled earlier this month, represents a big improvement over its predecessor, says pharmaceutical technology analyst Ruchi Mallya of

Novotech opts for open standards with Siebel

Australian contract researcher Novotech, having outgrown its homegrown SQL clinical trial management system, has signed on with Oracle for the Siebel CTMS. It's committed to $500,000 in licensing

Hamburg seeks something better than randomized trials for drug approvals

FDA Commissioner Margaret Hamburg wants to strengthen "a weak link in the chain" between science and drug regulation: the plodding randomized clinical trial. She'd like to see university-based

CRO Westat goes digital for clinical signoffs

Contract researcher Westat has adopted the CoSign digital signature solution for use in clinical trials and for its software development team. The solution from ARX lets researchers sign digitally

Transcept sweats FDA reaction to sleeping pill data

There's no telling how the FDA will react to data when two methods of statistical analysis have yielded conflicting results and the trial concerns a drug candidate for a condition having no treatment

Simulator provides early view of trial operations

Four major drug companies are using a simulation package at the planning stage of their clinical trials to study trial design operating characteristics, and one may soon be using the tool on 90

Savvy users set up to shift among cloud providers

Drug developers, beginning a push beyond the basics of cloud computing, are now looking for ways to move workloads between internal environments and multiple external clouds. There's now a need for

Supercomputer to boost drug design, personalized medicine research

A supercomputer for computation, simulation and data analysis in drug discovery will be tested by lucky early adopters early next year. The system is called The Beagle, after Darwin's ship....

Instem to use IPO funds to augment drug safety offering

Instem Life Science Systems, maker of early development safety assessment software, says it will use cash raised in its initial public offering in London to increase its appeal to big pharma. On the

Oracle's CDA 2.0 enhances transactional data analytics

Just eight months after Oracle unveiled its Clinical Development Analytics software, the software giant has released an upgrade. Version 2.0 takes the product beyond its initial data management

Galderma selects Medidata Rave, mentoring service

Swiss dermatology-product maker Galderma has standardized on the Medidata Rave electronic data capture and clinical data management platform. Medidata says it bested two other CTMS vendors in

Cmed boasts iPad version of Timaeus

E-clinical solutions provider Cmed Technology is making two announcements today regarding Timaeus, its unified study platform. The company is demonstrating version 5--to be available in January--and