-
Categories
-
Recent Posts
-
Recent Comments
- Joseph Francis on Europe’s Top Regulator Shows His Teeth
- Joseph Francis on Pfizer’s Virtual Trial Recruitment
- Nimer Yusef on Can “Clinical Data Integration on the Cloud” be a Reality?
Tags
CBI China conference CRO/Sponsor CROs data DIA drug development eClinical EDC EMA EU Europe European Medicines Agency facebook FDA IIR India IT JOhn Dalli Kayda Norman Ken Getz Lisa Henderson London oncology Oracle Partnerships in Clinical Trials patient/subject recruitment patients Peter O'Donnell Pfizer Pharmaceutical Executive Pharmaceutical Technology Philip Ward PRO R&D Regulatory REMS Sites social media subject recruitment subjects Tim Denman UK Wayne KubickJoin ACT for discussions, news, and more on
Monthly Archives: September 2009
Top 5 Mistakes Sponsors Make
They’ve been in industry for years and seen it all. And even committed a few of the faux pas they described two weeks ago during a presentation at RAPS 2009. They are consultants Jillian Reed and Amanda Weber, a dynamic duo with 20/20 hindsight who want to help others avoid making the top 5 mistakes [...]
What Good is eCTD If It’s Not Global?
We cover a lot about eCTD here at Applied Clinical Trials. This is because it is an emerging and large-scale global initiative that has the potential to transform the clinical trial submission process for the better.
But what advantages are there to eCTD if it doesn’t fulfill its intended benefits of being a globalized standard for [...]
Posted in Uncategorized Leave a comment
DIA Opts for Glamour and Gambles on Monaco
The Drug Information Association definitely sprang a surprise when it announced the location of next year’s European congress. The 22nd EuroMeeting will take place in Monaco from March 8-10.
On the surface at least, Monaco’s a slightly bizarre choice. There’s relatively little pharmaceutical industry in the immediate vicinity, and it’s a long way from the offices [...]
Uncovering Suicidality Signals in Subjects
Suicide issues and other psychiatric side effects from drugs have come to light, not only from actual drugs that treat psychiatric disorders but also from drugs for smoking cessation (Chantix), obesity (Acomplia, approved in Europe), acne (Accutane), and asthma/allergy (Singulair).
The Division of Psychiatry Products (DPP) of the FDA has established a policy on suicidality assessment [...]
FDA Approval for Dummies
Please know that the title of this blog is not a dig. It’s a play on the popular instructional series that’s produced books like Betting on Horse Racing for Dummies and Acne for Dummies.
In this case, as the name implies, it’s all about getting FDA approval—at least, what you can do to improve the odds. [...]
Industry Dating Sites, Hit or Miss?
How do you go about choosing your service providers? Maybe your company sticks with loyal and dependable past partners, maybe they’re chosen because of their reported success in other alliances, or maybe you put your faith in a partner recommended through word of mouth.
Whatever your selection process involves, there is a growing world of match [...]
Posted in CRO/Sponsor, IT, Labs, Sites Tagged partnerships, service provider, vendors Leave a comment
Have You Kept Every Copy of ACT Since Our Launch?
Here’s a challenging question for you: does anybody have a full set of printed copies of Applied Clinical Trials?
In case you’re curious, 207 issues have been published between the launch issue in May 1992 and this month’s edition. During our first year, we had combined July/August and November/December issues, but otherwise we’ve published a copy [...]
Yes Virginia, There is a Pandemic
Not sure about you, but I seem to come across varying degrees of severity regarding the current king of influenza H1N1. One week it’s front page worthy, the next it’s not. Granted, that’s how news works, but in this case, the result feels like confusion. So, what’s the deal?
Well, it is a pandemic. A Phase [...]
From the Editor’s Desk