EMA-developed method helps detect adverse events

A statistical signal-detection method shows promising results for early detection of adverse drug events. The method, developed by the European Medicines Agency and used in conjunction with adverse

GSK's Avandia trial faces recruitment battle

GlaxoSmithKline is having trouble recruiting subjects for the FDA-mandated trial of its beleaguered diabetes drug, Avandia. But not necessarily for its health risks. The pharma giant has closed two

SAS becomes FDA-submission-friendly

Old man SAS remains among the leading software packages for the statistical analysis of clinical trial data being submitted to the FDA. It debuted in 1976 for use on mainframe computers, writes Ian

Cloud computing aids mental illness, ophthalmic projects

Drug developers are beginning to put cloud computing and enterprise search capabilities to work for them. The tools are aiding development efforts by helping researchers and clinicians collaborate

Pilot lets docs tap database to find patient cardiac risk

An Internet-based program that helps determine an individual's risk of death, bleeding or restenosis taps a national cardiovascular database in its calculations. The well-informed program is part of

HealthMap adds more sources for disease tracking

Fortunately, the lack of a diagnosis confirmation remains an issue for HealthMap, the tool used last year to track the spread of H1N1. How much faith can the scientific community have in a tool that

Open source systems lure drug developers

The gradual spread of software automation in drug development may be getting a boost from open source systems. Most e-clinical systems today--from data capture and storage to trial management and

Researchers tackle randomized trial challenge

Researchers are tackling a major problem of group randomized trials: likely positive intraclass correlation among observations of individuals within the group. They have developed an index of extra

Ludwig Cancer Institute picks Medidata Rave

The nonprofit Ludwig Institute for Cancer Research Ltd (LICR) has chosen Medidata Rave as its electronic data capture and clinical data management solution. The Institute's clinical trials integrate

CRO launches tech group for data capture solution

Contract researcher Cmed Group has begun marketing its Timaeus data capture and management solution for clinical trials. The UK-based CRO has launched a collaborative arm, Cmed Technology, to sell

Cato, Merge extend relationship

Full-service CRO Cato Research has added etrials, a proprietary EDC solution from Merge Healthcare, to its existing Merge infrastructure. The addition was done via the solution provider's technology

NCI website aids cancer trial recruitment

An online tool lets cancer researchers collaborate and commiserate on subject recruitment. Much of the accumulated knowledge on cancer trial recruitment is scattered among those who have conducted

Roche uses PK/PD modeling to screen compounds

To cut down on drug failures at the clinical trial stage, Roche researchers are using pharmacodynamic/pharmacokinetic modeling for early prediction of drug efficacy. Roche created the PK/PD models

Medidata, Aris combine EDC and safety systems

Catering to customer choice in best-of-breed technology, Aris Global and Medidata Solutions have integrated the ARISg solution for pharmacovigilance and clinical safety with Medidata's Rave system

Lilly continues cloud computing efforts

In pharma circles, the cloud computing buzz has ratcheted down significantly from last summer and fall. But that's not to say that use of the cloud has stopped or that service providers have ceased

Amazon answers biopharma's cloud interest

Biopharma companies in Japan, China and India are currently more intent on investing in cloud computing than companies in other regions--so says market analyst Ovum, part of Datamonitor. The easing

NCI grant targets trial design improvement

A union of statistical and clinical experts is being put to a difficult task: improve the efficiency of the cancer clinical trial process. The multidisciplinary effort is being funded by a $12.5

OpenClinica gets case report form library

Users of the OpenClinica electronic data capture system have another free resource at their disposal: the OpenClinica Case Report Form Library. The web-based library, sponsored by Akaza Research,

Pfizer mines data to find compounds for repurposing

Collecting and combining data on existing compounds scattered throughout Pfizer (NYSE: PFE) was the challenge facing its global research indications discovery unit. Its goal was to find additional

Hemispherx forms data-monitoring team

A three-member independent data-monitoring committee will now oversee drug development, provide interim analyses of outcomes data, and ensure subject safety for Hemispherx Biopharma. The committee