2017

Overcoming the innovation malaise

Tuesday, February 21, 2017

The Pulse on Study Startup by Craig Morgan

Innovation is often cited as the “key ingredient” by organizations striving to sustain an advantage in the increasingly competitive global marketplace. The pace of technology change is relentless, with those who don’t embrace emerging trends often paying a hefty price. Simply “doing the same thing better,” however, is not enough.

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Industry makes a move on RTSM mobile apps

Tuesday, February 21, 2017

Parexel has launched a mobile app to extend its ClinPhone randomization and trial supply management (RTSM) service. The app employs barcode scanning technology that enables investigative site staff to track study medications and manage supply-related tasks throughout clinical trials.

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Three Questions: Dawn M. Furey, Merck & Co.

Tuesday, February 21, 2017

CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Barbara M. Bolten spoke with Dawn M. Furey, executive director, head of Global Operations, Global Clinical Trial Operations, Merck & Co. Furey leads the global alignment of strategies for implementation of clinical trial operations with a focus on trial feasibility and allocation, trial site documentation, enrollment/retention planning and support of project delivery. She also led the implementation of a cloud-based electronic trial master file solution, Veeva Vault eTMF.

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The CenterWatch Weekly, February 21, 2017

Tuesday, February 21, 2017

Regulatory uncertainties abound with presidential two-for-one order

The Trump administration seems to be serious about reducing the cost and burden of regulations. The question observers are asking is how those efforts will eventually shake out. One the administration’s latest initiatives is an executive order signed by the President that would require federal agencies, such as the FDA, to eliminate two regulations for every new one it wants to issue. The order also mandates that the cost of a new regulation should be offset “to the extent permitted by law.”

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CRISPR, Intellia, Caribou and ERS Genomics provide update on CRISPR/Cas9 U.S. patent

Friday, February 17, 2017

CRISPR Therapeutics, Intellia Therapeutics, Caribou Biosciences and ERS Genomics provided an update on the Patent Trial & Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO) decision on the motions filed by the University of California, the University of Vienna and Dr. Emmanuelle Charpentier (collectively, UC), on one hand, and the Broad Institute, Harvard University and the Massachusetts Institute of Technology (collectively, Broad), on the other, in the interference proceeding relating to CRISPR/Cas9 genome editing technology.

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