• Are You Ready for Vendor Oversight Scrutiny?

    Sep 11 | Guest Commentary | Regulators are paying increased attention to sponsors within the realm of vendor oversight. Clinical Trial Sponsors must include vendor oversight in any assessment of inspection readiness on their mid-stage development programs, and once the gaps have been identified, apply preventative actions across all outsourced programs in development.  

    Sep 10, 2012

  • Department of Health and Human Services Launches Trial Research with Medidata Databases

    Sep 10 | eCliniqua | The U.S. Department of Health and Human Services (HHS) has chosen Medidata’s trial cost benchmark data to support research into current cost data for clinical trials.  

    Sep 10, 2012

  • NextDocs Launches Trial Exchange

    Sep 10 | Product Brief |​ NextDocs Corporation has launched Trial Exchange, a simple, consumer-style interface for investigators and site staff to access and contribute essential documents for clinical trials. 

    Sep 10, 2012

  • PHT Corporation Announces NetPRO 1.3 for Patient Data Capture

    Sep 7 | eCliniqua | PHT Corporation has released NetPRO 1.3, the latest version of its web-based system for collecting patient and clinician data for clinical trials and post-marketing studies. 

    Sep 7, 2012

  • Technology to Replace Doctors?

    Sep 6 | VB | Vinod Khosla, co-founder of Sun Microsytems, says technology will replace 80% of doctors.

    Sep 6, 2012

  • More Choice in British Clinical IT Systems

    Sep 5 | Onmedica | IT supplier CSC has lost its exclusive rights to be the only provider of clinical IT systems in the North, Midlands and East of England.

    Sep 5, 2012

  • GUEST COMMENTARY: Can Outsourcing Reach Its Full Potential?

    Aug 29 | eCliniqua | GUEST COMMENTARY | Faced with a looming patent cliff, supply-chain issues and dwindling pipelines, Big Pharma has to take a closer look at outsourcing as a way to bolster development and manufacturing strategies. Electing for a leaner approach makes sense for many reasons but several key concerns must be addressed, ranging from innovation to emerging markets.  

     

    Aug 29, 2012

  • 211 Deaths in Six Months During Clinical Trials in India

    Aug 20 | Times of India | Investigators are probing why as many as 211 people have died in India in the first half of 2012 due to serious adverse events during clinical trials.

    Aug 18, 2012

  • Previewing the 2012 Barnett Clinical Summit

    Aug 17 | eCliniqua | This year’s annual Barnett Clinical Summit, which will be held this October, will focus on the theme of Optimizing Trial Performance, connecting clinical research experts, sponsors, sites and regulators.    

     

    Aug 17, 2012

  • DIA 2012 – Spotlight on eTMFs and Data Analytics (Part II)

    Aug 9 | eCliniqua | In part 2 of her annual tour of DIA e-clinical technology trends, Ann Neuer profiles innovative offerings in electronic trial master file (eTMF) solutions and clinical trial analytics from companies such as NextDocs Corporation, Sitrof Technologies and Comprehend Systems.  

    Aug 9, 2012

  • Microarray Clinical Trial Is Favorable for a Prenatal Gene Test

    Aug 9 | New York Times | The use of microarrays for prenatal testing to detect more genetic problems in a fetus than ever before could be headed toward wider use after encouraging results from a clinical trial sponsored by the NIH involving 4,400 pregnant women.

    Aug 9, 2012

  • Quinten’s Savoir Faire Approach to Clinical Data Mining

    Aug 6 | eCliniqua | A rapidly expanding French CRO called Quinten is quietly building an impressive client roster as it brings an innovative data mining approach to a broad expanse of the drug development pipeline – from early-stage target identification to its sweet spot in clinical trials and patient stratification.   

    Aug 6, 2012

  • New House Bill to Expose All Clinical Trials in Public Database

    Aug 6 | Mass Device | Four House Democrats aim to close loopholes in the U.S. government's clinical trial reporting requirements to ensure that all human studies are publicly disclosed online. The proposed Trial & Experimental Studies Transparency Act would require drug makers to report all studies and results publicly through the ClinicalTrials.gov website. 

     

    Aug 6, 2012

  • Sharp Dip in US Drug Approvals Forecast

    Jul 30 | Pharma Times | The US Food and Drug Administration (FDA) will approve fewer novel drugs in 2012 than it did last year, as the industry faces a number of ongoing operational risks, according to a new report.

    Jul 30, 2012

  • Parexel Alliance for Drug Development in South Korea

    Boston.com | Parexel International has been chosen by the Korea Drug Development Fund to help Korean biopharmaceutical companies develop and commercialize health care products for the global market.  

    Jul 19, 2012

  • DIA 2012 – Faster, Smarter, Easier (Part I)

    eCliniqua | Correspondent Ann Neuer takes her annual pulse of e-clinical trends from the vendor community exhibiting at the Drug Information Association (DIA) conference. In part 1 of a 2-part series, she profiles a few companies that stood out for me, including Greenphire, Oracle, and a couple of start-ups in the Entrepreneur Pavilion.

    Jul 13, 2012

  • ERT acquires Pittsburgh-based Invivodata

    Pittsburgh Business Times | Invivodata Inc. has been acquired by technology company ERT, making the latter it says the number one provider of clinical outcome assessments.

    Jul 9, 2012

  • Voice Algorithms Spot Parkinson's disease

    BBC News | British mathematician Max Little has developed a cheap, non-invasive test to diagnose Parkinson's disease based on his discovery that symptoms can be detected by computer algorithms that analyse voice recordings. He is now recruiting 10,000 volunteers to have their voices recorded.

    Jul 5, 2012

  • How to Tell When A Drug Company Fibs About Clinical Trial Results

    The Street | Reporter Adam Feuerstein diligently dissects an upbeat official announcement from Osiris about its Prochymal heart attack study, parsing the language of clinical trial results while finding independent sources of truthful information, such as clinicaltrials.gov

    Jul 3, 2012

  • Medidata, Tufts Study Leads News Roundup from DIA 2012

    eCliniqua | Medidata Solutions, BBK Worldwide, ArisGlobal and iGate were among the e-clinical companies making news at the annual gathering of the Drug Information Association (DIA) in Philadelphia.

    Jul 3, 2012