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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Can the Life Sciences Industry Adopt Cloud Computing?

posted on 10th September 2014 in Solutions

Life sciences companies are adopting cloud computing and software-as-a-service (SaaS) IT models, particularly in the areas of sales and marketing. There is an opportunity to extend the cloud’s impact into areas such as R&D and supply chain. However, there are legitimate concerns about protecting intellectual property and demonstrating compliance with industry regulations. The primary two […]

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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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