What are the Costs in Sharing Clinical Data?

posted on 7th March 2014 in News & Events

There is great interest in encouraging clinical data sharing for research (see our recent post on the Accelerating Medicines Partnership); however, there is little discussion about the costs of sharing clinical data and who bears those costs. The Journal of the American Medical Association (JAMA) recently published an article online outlining models for sharing clinical and […]

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How will the AMP’s Shared Data Model Improve Drug Development?

posted on 12th February 2014 in News & Events

The National Institutes of Health (NIH) recently announced the Accelerating Medicines Partnership (AMP), a novel collaborative partnership with 10 life sciences companies and several non-profit organizations. This first-of-its-kind partnership is focused on identifying and validating the most promising biological targets to treat Alzheimer’s, diabetes, rheumatoid arthritis, and lupus. These are among the most prevalent conditions in […]

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How Will Clinical Trials Benefit from $1,000 DNA Sequencing?

posted on 28th January 2014 in News & Events

Did you see the recent announcement from Illumina, the leading maker of DNA sequencers? Their new machine (known as the HiSeqX Ten) will be able to sequence the DNA of a human cell for $1,000. I’m excited about this news and the possibility of this being the beginning of an era of low-cost, industrial-scale sequencing […]

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C-Suite Views on Opportunities and Barriers for Clinical Services

posted on 16th January 2014 in Partners

Recently PharmaVOICE asked me and other C-Suite executives from around the clinical services ecosystem what we see as opportunities and barriers for improving the clinical development process. I’m excited about the promise of genomics as an opportunity to innovate the process, which can lead to increased success and decreased costs. The January 2014 issue of […]

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Can You Commit Risk-based Clinical Trial Monitoring?

posted on 15th January 2014 in News & Events

There is much discussion by regulatory bodies about the benefits of risk-based approaches. One area of focus is clinical trial monitoring. The Food and Drug Administration (FDA) and European Medicines Agency (EMA) have both issued guidance recommending sponsors shift away from traditional approaches of clinical trial monitoring toward a quality risk management approach. Many sponsors […]

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Make 2014 the Year to Leverage Clinical Trial Data

posted on 16th December 2013 in News & Events

It is the time when I think about the progress made this year, and look forward to new things in the coming year. I recently ran across a report from Deloitte and Thomson Reuters titled “Measuring the Return From Pharmaceutical Innovation 2013”. The report aims to quantify the return on investment leading life sciences companies […]

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Are You Ready to Move Your Clinical Trial Processes to the Cloud?

posted on 13th December 2013 in Solutions

Life science companies are struggling to enhance the productivity of their R&D processes. A new paradigm is emerging that moves the conduct and management of clinical trials to cloud-based applications. With cloud-based technologies, sponsors can implement an end-to-end data management strategy to transform their clinical development life cycle processes including data acquisition, storage, aggregation, and […]

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How Data Aggregation and Visualization Transforms Clinical Trials

posted on 4th December 2013 in Recommendations

There are intense pressures on clinical trial sponsors to change the way clinical research is conducted in order to decrease costs and speed up the research and development process. There is also increased scrutiny by regulatory agencies such as the Food and Drug Administration and European Medicines Agency, and compliance with regulations is critical. The ultimate […]

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Is Your Clinical Trial Data Efficiently Integrated?

posted on 3rd December 2013 in Solutions

Life sciences companies are drowning in data! It is a challenge for life science companies to know what data they have, and it is nearly impossible for them to look at their clinical trial data holistically and act on it. Technology continues to evolve and is dramatically changing how clinical trials are conducted. In particular, […]

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Leverage Technology For Data Aggregation from Disparate Sources

posted on 14th November 2013 in Solutions

Sponsors are facing intense pressures to change the way clinical research is conducted in order to decrease costs and speed up the research and development process. Equally important data management challenges are: 1) The ability to enhance data sharing between partners such as study sites, CROs, clinical trial monitors, and development partners such as small or […]

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