• Glaxo Agrees to Pay $3 Billion in Fraud Settlement

    Jul 3 | New York Times | In the largest settlement involving a pharmaceutical company, the British drugmaker GlaxoSmithKline has agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants for unapproved uses and failing to report safety data about a top diabetes drug.

    Jul 3, 2012

  • DIA: Drug, Food Safety Trumps Jobs, says FDA's Hamburg

    Philly.com | Despite the global economic turmoil that has affected the drug industry, regulatory leaders from North America and Europe, including FDA commissioner Margaret Hamburg, opened the 2012 DIA convention saying that safety and science must not be compromised for the sake of jobs that might be created if rules were relaxed.  

    Jun 29, 2012

  • COMMENT: 2012 Survey Demonstrates Growth in eTMF and Impact of Standards

    eCliniqua COMMENT | In a Guest Commentary, Maryanne Quinn and Fran Ross discuss the results of a new survey that indicates a significant growth in the number of organizations transitioning to electronic Trial Master Files (eTMF).   

    Jun 28, 2012

  • Roundtable on Translational Cancer Research Trends

    June 18, 2012 | Bio-IT World | One of the highlights of the 10th anniversary Bio-IT World Conference last April was a plenary roundtable on translational cancer research, featuring four outstanding cancer researchers: computational biologist John Quackenbush (Dana-Farber Cancer Institute); drug discoverer Julian Adams (Infinity Pharmaceuticals); clinical researcher Jose Baselga (Mass General Hospital, Boston); and geneticist Sir John Burn, (Institute of Genetic Medicine, Newcastle University, UK/QuantuMDx).

    Jun 18, 2012

  • Clinical Trial Registries Step Up Reporting Requirements

    June 18, 2012 | eCliniqua | Clinical trial registries will be upping the ante by requiring more disclosure from biopharmaceutical companies, but it’s not yet clear what additional information will be required or when compliance will be expected. The next round of disclosures will expand the level of transparency in widely used databases such as ClinicalTrials.gov and EudraCT due to legislation requiring industry, academia, and government to be more forthcoming with clinical trial specifics.

    Jun 18, 2012

  • Foundation Medicine, Novartis Partner for Clinical Trial Enrollment

    Jun 11 | News Brief | Foundation Medicine and Novartis are partnering on cancer drug testing. Novartis plans to use Foundation's technology as part of its cancer trial enrollment process over the next three years, focusing on Phase 1 and 2 oncology clinical programs. 

    Jun 10, 2012

  • Clinical Ink Named Cool Vendor for EDC System

    Jun 11 | Gartner | Clinical Ink has been named a Gartner Cool Vendor for 2012 with analysts saying that the technology has "significant disruptive potential in the area of EDC systems." Clinical Ink's technology began development in 2009. 

    Jun 10, 2012

  • Agility Clinical CRO to Work With Small Drug and Device Companies, Pediatric Focus

    May 31 | News Brief | New specialty CRO Agility Clinical, Inc., was announced yesterday. Agility will focus on providing customized clinical research and consulting services to small and virtual biotechnology, specialty pharma, medical device and diagnostic companies. The company says it has a "special interest" in pediatric drug development.

    May 31, 2012

  • PCORI’s Research Agenda is Broad, Cost-Neutral

    May 29 | eCliniqua | The role of cost and patients in comparative effectiveness research (CER) were among the themes of a Post-Approval Summit held earlier this month at Harvard Medical School*. So, too, was the agenda and funding priorities of the latest actor in the CER arena: the independent, multi-stakeholder Patient-Centered Outcomes Research Institute (PCORI). 

    May 29, 2012

  • Building Electronic Clinical Trials is Grueling and Slow—Recent Survey

    May 21 | eCliniqua | The tedious process of building an electronic clinical trial is a stubborn bottleneck requiring too much time and too many resources. Those are the topline results of a 2011 survey conducted at two annual meetings—the Drug Information Association (DIA) and the Society for Clinical Data Management (SCDM). Cmed Technology, a UK-based provider of eClinical solutions developed and administered the survey, which resulted in 87 respondents from 55 companies. 

    May 21, 2012

  • Lung Cancer Trial Combines Blood Test and Imaging

    May 7 | News Brief | National Jewish Health is seeking to refine and improve lung-cancer screening by combining a blood test with CT imaging to detect disease earlier and more effectively. The trial combines a CT chest scan and the EarlyCDT-Lung blood test to screen for cancer.

    May 7, 2012

  • Quanticate Opens Bangalore Office

    May 4 | eCliniqua | Quanticate is expanding its contract research capabilities for clinical trials in India with the announcement of a new office in Bangalore. The new office will take further advantage of growing clinical trials opportunities in India. 

    May 3, 2012

  • CDISC Releases Protocol Representation Toolkit

    May 2 | News Brief | CDISC has released the first iteration of a Protocol Representation “Toolkit” for clinical research. The purpose is to make it easy for authors of the research plan or protocol to reap the benefits of the Protocol Representation Model (PRM), which has been developed over the past decade by global clinical research experts from academia, industry and government.

    May 1, 2012

  • PHT Releases New Patient Reported Outcomes Tool

    Apr 24 | eCliniqua | PHT Corporation has announced the newest version of StudyWorks, its online clinical trial management system. The new release includes dashboards that display secure and configurable, quick-read highlights of the most relevant information for a given role and enhanced performance and scalability for global mega trials. 

    Apr 24, 2012

  • BioClinica Partners with Paragon Solutions

    Apr 24 | News Brief | BioClinica is partnering with Paragon Solutions, an advisory consulting and systems integration firm that specializes in enterprise information management. BioClinica customers will utilize Paragon's resources and expertise to support large-scale integration of BioClinica's eClinical solutions across a variety of technology partnerships and client implementations.

    Apr 23, 2012

  • eClinical Technology: What Would Steve Say?

    Apr 23 | eCliniqua | Guest Commentary | The untimely passing of Steve Jobs led to extensive media coverage and a best-selling biography examining his life and legacy. Jobs was both a passionate visionary and an eccentric renegade, and his many successes rose from a set of principles and practices that changed how we develop, use, and think about technology. The Jobs legacy pertains equally to consumer devices and business applications such as eClinical systems, so let’s pause and consider “What would Steve say about eClinical?" 

     

    Apr 23, 2012

  • DecisionView’s Consortium Approach to Optimizing Enrollment

    Apr 16 | eCliniqua | For industry leader Merck, country-specific and site-level performance metrics have been among the early wins from the DecisionView Enrollment Benchmarks data set, says Brendan O’Neill, Merck’s director and head of global trial optimization. The pharmaceutical giant last June joined peers GlaxoSmithKline and Roche in working with DecisionView to turn their combined operational patient enrollment data into a cross-industry set of clinical trial enrollment benchmarks. 

    Apr 16, 2012

  • invivodata Integrates Consulting Division

    Apr 12 | News Brief | In response to regulators’ increasing emphasis on patient centered data, including patient-, clinician-, and observer-reported outcomes (PRO, ClinRO, and ObsRO), invivodata is integrating its consulting division—formerly PRO Consulting—into its portfolio of Clinical Outcome Assessment (COA) consulting services.

    Apr 12, 2012

  • Better Site Contracting Through Improved Negotiation Efficiency

    Apr 10 | eCliniqua | Guest Commentary | A 2009 report by Thompson Centerwatch cites contract/budget negotiation and approval as the leading cause of delays in study starts. In fact, contract and budget negotiations cause more delays than the recruitment and enrollment of patients. With life science companies being pressured to do more with less, the hunt for increased efficiency is widespread. Life science companies that embrace technology to improve manual processes like site budgeting and contracting can lower their times to get studies started, improve management oversight, and increase the ability to make timely decisions, which ultimately leads to more favorable results. 

    Apr 9, 2012

  • iPad App for Clinical Trial Informed Consent

    Apr 10 | News Brief | Mytrus has released its iPad app for informed consent in clinical trials prior to patient enrollment. Using animation and other visual imagery, the Mytrus iPad application is the first in the industry to condense the complex and critical disclosure information required at the start of a clinical trial into an easy-to-understand, digitized format. 

    Apr 10, 2012