DIA Biosimilars 2013

Department of Health and Human Services

Proposed Common Rule updates focus on consent, definitions, streamlined IRB review, data protection

Monday, October 31, 2011 08:02 AM

A 20-year-old federal policy for protecting human subjects known as the Common Rule is soon to be updated in ways that could modernize how the industry approaches the ethics, safety and oversight of human research.

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Cenduit: Now with Patient Reminders

Survey debunks consumer belief that all new FDA-approved drugs are better than the old

Monday, September 26, 2011 08:00 AM

Many consumers believe drugs do not receive FDA approval unless they are extremely effective and don’t have major side effects. At the same time, it’s a commonly held belief that new drugs are always safer than drugs that have been on the market for many years.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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