News

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

Clients re-up with growing DATATRAK

DATATRAK is rockin' and rollin': the e-clinical technology and service provider has announced two contract awards and a hire, all in the early days of October. The contracts involve an enterprise

J&J teams with Microsoft for biologics

Johnson & Johnson's IT-savvy pharma R&D group turned to Microsoft Research for help in expanding its small-molecule drug-development platform into biologics development. The attraction: the

Free smartphone app evaluates need for radionuclide imaging

Clinicians will be able to access via smartphone guidelines for determining when a patient needs cardiac radionuclide imaging. The app, developed by Astellas, is called Appropriate Use Criteria for

Verizon cloud hosts app that measures wound-healing progress

GWR Medical, a provider of treatments for open skin wounds, has sent its IT infrastructure to the cloud via Verizon. The Pennsylvania company provides products and services that address a tricky

BioClinica EDC deal should help settle investor Nicusa

E-clinical solutions provider BioClinica, not skipping a beat since a recent investor tantrum, has signed a three-year deal for enterprise-wide EDC technology and data management services with a top

Drug-use software aids may siphon development funds

Positive signs of the cost and time benefits of adaptive trial designs may be arriving just in time. Healthcare reform promises to deliver a big blow to drug developers. But it may also boost