Clinical Development Risks and Issues in a COVID-19 World

Posted by Jonathan Rowe on Fri, Mar 20, 2020

Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).


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Is Coronavirus the Spark That Telehealth Needs?

Posted by Victoria Summers on Fri, Mar 13, 2020

Earlier this year, experts agreed that telehealth was poised to become mainstream in 2020. Spurred by broad access through smartphones and supported by health plans across the U.S., telehealth finally has the financial reimbursement and regulatory guidelines to enable patients and physicians to connect online. But now, COVID-19 has come on the scene. With the outbreak of the coronavirus in China and its rapid spread around the world, private companies and governments have encouraged people to quarantine themselves if they believe that they may have the virus. But how do patients know if they have it? If they suspect that they do have it, how can they access care in a way that doesn’t expose others? And if patients have health questions unrelated to coronavirus, wouldn’t they prefer to stay away from clinics and hospitals to decrease their risk of exposure?


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What China’s Latest Drug Negotiations Mean for Global Pharma Companies

Posted by Crystal Lam on Wed, Jan 22, 2020

Sonia Yan and Daniel Blessing co-authored this blog post with Crystal Lam.

China’s National Healthcare Security Administration (NHSA) recently released the outcomes of its 2019 National Reimbursed Drug List (NRDL) negotiations: 70 of 119 new therapies were successfully listed. This record outcome more than doubled the number of therapies reimbursed through China’s negotiation pathway, which was formally implemented in 2017.


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What Pharma Companies Are Getting Wrong About Executing Brand Strategy

Posted by Dan Ogletree on Tue, Aug 06, 2019

Oftentimes in pharma, developing and then executing on a strategic brand goal is like playing a game of telephone: The message gets interpreted—or misinterpreted—by several different teams or vendors all acting independently of each other. The result? An effort that’s disjointed and inefficient, and oftentimes misaligned with the initial strategic objective—in effect, a botched message.


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The Evolving Data Landscape Will Transform Healthcare. Here Are Four Trends to Watch.

Posted by Paul Darling on Fri, Jun 28, 2019

Oladele Ojo co-wrote this blog post with Paul Darling. 

The healthcare system generates approximately a zettabyte (a trillion gigabytes) of data each year, which includes both classic data from sources such as EHRs, diagnostics and genetics, as well as newer data sources such as gut biome sensors, wearable devices and environmental monitors, and social media. Consequently, it’s now possible to quantify a person across three dimensions of human existence: biological, environmental and digital/social.


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