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 SCDM 2014 Annual Conference

posted on 7th October 2014 in Data Talk

I just returned from a trip to Las Vegas where I attended the annual conference of the Society of Clinical Data Management (SCDM). It was a great opportunity to hear about the current areas of interest for Clinical Data Managers. I had the opportunity to attend many sessions over two days, and here are some […]

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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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How Corporate Culture Impacts Business Success: 4 Key Tactics

posted on 23rd September 2014 in Recommendations

I recently ran across a blog post by John Coleman on the Harvard Business Review blog that cited research conducted by James L. Heskett that culture “can account for 20-30% of the differential in corporate performance when compared with ‘culturally unremarkable’ competitors.” I’ve been involved with a number of organizations throughout my career, and I’ve […]

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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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What Brilliant Insights Do You See In Clinical Trial Data?

posted on 26th June 2014 in Solutions

Sponsors want to leverage their clinical trial data to support critical decisions. To do this clinical data needs to be easily accessible and consolidated for sponsors to have a complete view of the efficacy and safety of a treatment. What can a clinical data repository do? Today most sponsors are only able to view siloed […]

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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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