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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
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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
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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
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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?"
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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Budget Woes Stall Clinical Trials and Stymie Sites
Feb 20 | eCliniqua | Imagine buying a new car or a new house but not knowing the price until the papers have already been drawn up and it’s time to sign on the dotted line. According to Christine Pierre, President of RxTrials, that’s exactly the situation investigative sites face as they attempt to negotiate budgets and contracts for clinical trials.
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FDA Releases Social Media Guidelines
Jan 9 | Scientist | The Food and Drug Administration has released its guidelines for how pharma companies use social media to respond to questions about off-label use of drugs and devices. But they're still not as comprehensive as many hoped for.
Jan 8, 2012
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Expect Measurable ROI of Innovation in 2012
Jan 5 | eCliniqua | Guest Commentary | In 2011, biopharma sponsors continued to rely on an increasing number of contract research organizations (CROs) and eClinical technology solutions to support the research of drugs and related devices. Biopharma sponsors’ most precious asset: controlled access to clinical data throughout the course of trials, became more crucial and challenging than ever.
Jan 5, 2012
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CDISC and IMI Sign Standards Agreement
Dec 19 | eCliniqua | The Innovative Medicines Initiative Joint Undertaking (IMI) and the Clinical Data Interchange Standards Consortium (CDISC) have signed an agreement and initiated activities to enhance the use of information gathered for the purpose of developing safer, more effective innovative medicines for patients.
Dec 18, 2011