How Data Standards and Technology Empower Life Sciences Companies

posted on 2nd December 2014 in News & Events

Costs to bring a new drug to market are staggering, and life sciences companies face intense pressures to decrease costs and bring new drugs and treatments to market more quickly. The life sciences industry is also facing increasing complexity with the types of data available such as genomic biomarkers, and the increasing amount of data […]

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Highlights from the Annual SQA Fall Symposium

posted on 25th September 2014 in News & Events

What a great week in Denver!  I started the week co-chairing the annual Fall Symposium. This year it was a combined effort between the Rocky Mountain SQA local chapter and the Regulatory Forum Council (RFC).  My co-chair, Chris Both, President of the Rocky Mountain Chapter, and myself representing RFC had a two day program focused […]

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Accelerating Adoption of Risk-Based Monitoring in Clinical Trials

posted on 5th September 2014 in News & Events

Risk-based monitoring (RBM) is the future direction for modernizing how clinical trials are conducted. This spring Medidata and TransCelerate BioPharma Inc. announced a partnership to analyze and assess the relative contribution of source data verification (SDV) to overall clinical data quality. The study is extensive and will leverage operational data and business analytics solutions from Medidata. […]

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Highlights from Day 1 of the Medidata Symposium

posted on 25th April 2014 in News & Events

Day 1 of the Medidata Symposium was great! The keynote presentations and sessions were insightful. Below are a few highlights I’m taking away from the symposium: Theme 1—Why settle? “Challenge your technology providers,” Jason Carlson, Gilead Sciences In the future there will be an increased use of analytics to provide a view across data sources […]

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4th Global QA Conference & 30th SQA Annual Meeting

posted on 11th April 2014 in News & Events

Here’s a wrapup of my experience at SQA 2014 in Las Vegas. Key components of the week: 2 Days of the SQA Quality College 4 Days of the SQA Annual Meeting Countless networking opportunities An amazing Elton John concert What a week! As I reflect on the 4th Global QA Conference & 30th SQA Annual […]

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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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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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