elluminate® Featured for Innovation in the Life Sciences Industry

posted on 16th April 2015 in News & Events & Solutions

The April 2015 issue of PharmaVOICE magazine shines a light on the innovators and innovations that are changing the life-sciences industry. PharmaVOICE readers identified the companies, products, tools, technologies, and processes that are making a difference in the lives of patients. An independent panel of industry experts reviewed hundreds of companies, products, and technologies, and […]

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elluminate For Data Aggregation, Standardization, and Analytics

posted on 21st January 2015 in News & Events

We are pleased to announce the latest release of elluminate®, our end to end clinical data repository and analytics platform. elluminate is an industry changing platform that empowers users to integrate, manage, standardize, and analyze their clinical and operational data. The elluminate platform integrates and standardizes clinical and operational data, regardless of source, to enable […]

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Accreditation Achieved on Medidata Rave Safety Gateway

posted on 19th December 2014 in News & Events

We are pleased to announce our latest accreditation, which is to customize and support the Medidata Rave® Safety Gateway. The Rave Safety Gateway is a configurable EDC-to-safety system interface that enables safety and data managers to collect and transmit safety data from investigational sites to a safety system, efficiently and accurately. Timely reporting of serious […]

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On the Horizon: Discussing Key Life Sciences Trends for 2015

posted on 9th December 2014 in News & Events

In the November/December 2014 issue of PharmaVOICE magazine is an article looking ahead to what is on the horizon in 2015. The article provides expert insights across all sectors of the life sciences industry. The article identifies 10 mega trends that will have the most impact on the industry and shape the future of healthcare. […]

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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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