June 26, 2019Regulatory

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Finding Quality and Speed

IRB Selection Tips

Not sure how to choose an IRB? We’ve got a list. more...

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10-Point Checklist

Regulatory SaaS From Mission3

How should regulatory documents and clinical projects be managed? Electronically, says Dirk Beth. Mission3’s approach and a pox on attachments. more...

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A Quickening Process

Trials Thriving In Brazil

This emerging market just got more competitive with some new, potentially exciting regulatory changes. The first in a series. more...

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"No Doctor Left Behind"?

[Leaked] Email To Barack Obama

In a rare gaffe, Barack Obama’s team mis-routes a confidential strategy memo. A sobering look at what one advisor is thinking. more...

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Silo vs. Life Cycle

Octagon’s End-To-End Vision

The software company is rethinking the way data is collected with the regulatory process in mind. more...

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With a new emphasis on databases and systems, FDA and its CDER branch prepare for a post-Vioxx landscape. more...

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100 Languages Spoken Here

Profile: Global Language Solutions

With ISO certification, a California firm tries to lower regulatory risks inherent in translation by ensuring high quality—and avoiding mistakes. more...

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Coast: Ethics & Efficiency

Inc. List’s Only IRB

Coast IRB just made Inc. magazine’s list of America’s 5,000 fastest-growing private companies. It’s the only IRB ever to do so. more...

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Rejecting Schering's Sugammadex

Pre-Election FDA On Lockdown

Mark Mansour of the Bryan Cave law firm says the FDA is on hold while America selects a president. more...

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FDA, EMEA Milestone

Critical Path Win: New Biomarkers

Arizona’s Critical Path Institute gets industry, FDA and EMEA to agree on seven renal biomarkers. more...

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Stopping Traffic

Coast IRB’s DIA Psychic

Close encounters on the 2008 DIA exhibit floor. Plus Nintendo Wiis, flat-screen TVs, stuffed animals and Russian dolls. more...

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New FDAAA Paperwork

New FDA Form 3674, Explained

The FDA’s new Form 3674 is an attestation that a trial has been registered in clinicaltrials.gov. more...

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At Outcome’s Post-Approval Summit at Harvard, CDER head Janet Woodcock walked the audience through what FDAAA means. more...

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Webinar: Tessella, United Biosource

Adaptive Designs: The Regulatory Issues

Two leading firms, Tessella and United Biosource, discuss the perception that regulators are trying to slow down the adoption of adaptive designs. more...

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Profile: Phlexglobal

Mastering The Trial Master File

More global locations and outsourcing can make for a messy process to generate a trial master file (TMF). Phlexglobal bundles services and software to help. more...

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Sponsors in denial?

2008 eCTD Train Wreck?

Warren Perry of Qumas warns that some of the industry will be unprepared for the FDA insisting on its long-planned transition to the eCTD. more...

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