News

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

Investigator warned for record-keeping violations

"Remember the basics!" is one message that Joel Picus of Washington University of St. Louis will likely carry away from FDA Warning Letter 10-HFD-45-09-02. In the letter, dated last month but

Data drives adaptations in I-Spy 2 cancer trial

A cancer drug trial volunteer apparently on the road to recovery may be strengthening the case for adaptive trial design. The seeming success of 37-year-old breast cancer sufferer Kerry Landreth in

PharmaVigilant bolsters site payment system

Trial technology provider PharmaVigilant has released PaySite 2.0, a dashboard-based payment system that lets sponsors program site payments based on performance and individual contracts. Users can

Chinese consider trial protocols for traditional meds

Drug experts in China are creating clinical trial protocols for traditional Chinese medicines in an attempt to hasten market acceptance. Traditional development yields customized treatments based on

Investor calls for exec resignations at BioClinica

The leadership at e-clinical solutions provider BioClinica has a "flawed" acquisition strategy and is "destroying shareholder value," complains investor Nicusa Capital. In addition, "management has

Lilly's MuSE optimizes trial design

Eli Lilly is enjoying improved dose/response relationships, better trial dose starting points, and the ability to simulate multiple trial endpoints, thanks to cloud computing. These cloud-based trial

IT answers sticky trial-startup challenges

Subject recruitment difficulties are driving solution developments based on Web 2.0 capabilities and data mining, according to John Johnson, associate director for statistics at Cato Research, in Ask

FDA updates, finalizes trial safety reporting rule

The FDA's final rule on safety reporting requirements during clinical trials, announced on Tuesday, requires certain information previously not required to now be reported within 15 days. The rule

EU moves toward web portals for adverse events

The European Parliament has signed off on the Pharmacovigilance directive, which would require national governments to set up medicine web portals containing information on drug products and side

Radiologist reviews iPad imaging apps

Expect "a lot of the iPad in our departments--and, more importantly, outside the radiology suite," says Sam Friedman, CTO and director for nuclear medicine at Pitts Radiology in South Carolina.

Medical center hires social media coach

The Swedish Medical Center in Seattle has a social media coach who encourages doctors and investigators to take advantage of the Internet podium. The goal, she says, is to find those who have the

Cloud to separate biotech from big pharma

Cloud computing may provide the wedge that conclusively separates big pharma and little biotech into two distinct industries. The current business model joins them in an uneasy relationship in which

Merck earns 4th spot on InformationWeek 500

Trial subjects and patients alike forget things, and that can affect clinical trial data as well as treatments. That fact served as the genesis within Merck of a group whose mission is to take full

IRB automates document processes for protocol review

Independent institutional review board Copernicus Group has announced CGIRB Connexus, a web portal for document management. The system integrates the management of electronic documents with a

Lilly lets researchers expense cloud time

Eli Lilly continues to bolster its use of the cloud to help drug researchers work at their own pace. The pharma cloud pioneer's IT group has created templates for scientists to use in commissioning

Cancer drug trial poses ethical dilemma

PLX4032 raises the seemingly straightforward question: data or life? The melanoma drug candidate from Roche highlights the sometimes opposing needs of doctors and regulators when it comes to

Professional guinea pigs show data disregard

Tox21 promises to be good news for animals, but it's bad news for Phase I trial subjects. Success of the federal collaboration to model the effect of chemicals on humans, if it can minimize toxicity

Akaza measures rise in OpenClinica users, submissions

Akaza Research, provider of the OpenClinica open-source clinical trial software, is boasting a 246 percent increase in users over the past year, pushing the total beyond 10,500. The stat comes from