News

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

Pending EU regulation drives Virtify PIM solution

The European Medicines Agency is just months away from simultaneously easing the onerous process of product information review for regulatory submissions--for drug developers and regulators

Report: Software makers can aid Tox21 work

In silico technology providers could be assets to Tox21, the federal collaboration that's developing ways to predict via modeling how chemicals will affect human health. The FDA just joined the

IT becomes vendor ops inspector via SaaS

SaaS changes the IT role from implementer of its own operations to inspector of vendor operations, say analysts at Gartner. As inspector, watch for gaps between hype and reality. For example, 90

Investigator disciplined for data-faking

The FDA has gone easy on the leader of a clinic who allegedly submitted fake data in a drug trial. Physician Daniel Berger will continue his HIV drug trial work, but it will now be under the eye of

FDA takes second look at meta-analysis

The drug industry needs new ways of dealing with conflicts in safety data. The conflicts have to be resolved faster, and more definitively. That's the conclusion of Forbes' "Medicine Show" columnist

New media use rising in subject recruitment

E-mail and text-message visit reminders are among the newer subject-retention tactics being practiced by trial managers. But little effort is devoted to retention, says Cutting Edge Research.