• 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

  • Oracle Acquires ClearTrial Clinical Software

    Apr 2 | PC World | Oracle acquired ClearTrial late last week for an undisclosed amount in a deal expected to close in the first half of the year. Oracle hopes to combine ClearTrial's cloud-based clinical trials software offerings with its existing portfolio including tools that came with the 2010 Phase Forward acquisition. 

    Apr 2, 2012

  • DIY Clinical Trials

    Apr 2 | Wall Street Journal Blog | DIY science is growing in popularity, especially as sequencing costs fall and genomics becomes more accessible. So it's not surprising that the DIY clinical trial is gaining ground as well. An investment advisor in Silicon Valley launched her own clinical trial on the type of vitamin B she, and others with her genotype, should take.

    Apr 2, 2012

  • Lessons Learned: Sites Leveraging CTMS to Increase Efficiencies, Boost Bottom Line

    Mar 23 | Guest Commentary | It’s no secret that the clinical trial environment is changing, with the constant need to increase efficiencies and overall performance while reducing costs. However, it’s worth noting that there are sites successfully implementing strategies to meet these demands through the implementation of clinical trial management systems. The Lynn Health Science Institute (LHSI) is one such site. As an emerging leader bringing new drugs to market through its clinical trials program, LHSI has completed over 300 clinical trials, working with over 200 pharmaceutical companies and CROs.   

    Mar 22, 2012

  • GNS Healthcare Aids Search for Fresh Leads on CHF Readmissions

    Mar 19 | eCliniqua | Hypotheses culled from real-world outcomes data will be getting large-scale testing by Harvard-affiliated Brigham and Women’s Hospital. The advanced analytics of GNS Healthcare are being applied to de-identified data from electronic health records (EHRs), pharmacy data, and administrative claims information to determine what factors contribute to adverse drug reactions and hospital readmissions in patients with congestive heart failure (CHF), says David Bates, director of the hospital’s Center for Patient Safety Research and Practice. 

    Mar 16, 2012

  • Clinical Reference Laboratory Affirms CRO Position in Asia

    Mar 8 | Manufacturing Chemist | Clinical Reference Laboratory (CRL), a US-based provider of central laboratory services for clinical trials with a European operation in Cambridge, UK, has fully integrated its long-standing laboratory partner Phoenix Pharma Central Services in Singapore. 

    Mar 18, 2012

  • Major Milestone in Development of New CDISC Device Standard

    Mar 6 | News Brief | The Clinical Data Interchange Standards Consortium (CDISC) announced a public review and comment period for the new CDISC Device Standards and encouragement for device companies to be involved in CDISC activities. This marks the first development by CDISC of standards for device trials. 

    Mar 18, 2012

  • February New Products

    Feb 27 | Bio-IT World | New products for February including new products from DATATRAK for clinical trial randomization and supply management, and DecisionView's latest version of StudyOptimizer for pateint enrollment planning, tracking, and forecasting.

    Mar 18, 2012

  • February News Briefs

    Feb 23 | Bio-IT World | February news briefs from around the Bio-IT industry including CDISC's expansion in Europe with the Innovative Medicine Initiative and the European Organisation for Reserch and Treatment of Cancer.

    Mar 18, 2012