June 26, 2019Regulatory

Finding Quality and Speed

IRB Selection Tips

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

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...

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...

"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...

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...


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

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...

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...

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...

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...

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...

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...


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

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...

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...

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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