Author Archives: Lisa Henderson

Government Funded Research, Is it That Different?

In December 2011, the President’s Bioethics Commission released its “Moral Science: Protecting Participants in Human Subjects Research.” The report was ordered by President Obama following an October 2010 revelation that the US Public Health Service supported unethical research in Guatemala from 1946 to 1948 that involved intentionally exposing thousands of Guatemalans to sexually transmitted diseases [...]
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Your Help Needed on Survey

This survey https://www.surveymonkey.com/s/96RD6CH will close on Friday, so this is your chance to share your views on Clinical Trial Agreements. It is widely known that the site agreement negotiations of Clinical Trial Agreements are a delaying factor in clinical trial start-ups. Applied Clinical Trials and Salvius Legal BV are collaborating on a survey https://www.surveymonkey.com/s/96RD6CH to obtain [...]
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The Patient Centered Way

Not quite settled into 2012 just yet, but already the radar seems to be tilting toward subject/patient recruitment and retention. Sure, it’s always been on the clinical trials screen, and it comes up as a topic year after year. But indications are this year, it could signal the true bellwether of change that frankly, is [...]
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2012: Hot Topics

There are predictions, resolutions, and lists that fill out end of year reading for every industry. I’m hesitant to go out on a limb and make predictions because the future is fickle, and resolutions only work with a firm direction. Neither of these will work for the clinical trials industry this coming year. But what I [...]
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Why Cardiac Safety Matters

In a recent Webinar I moderated “Current Issues in Cardiac Safety” sponsored by PPD, we polled the audience as to how much impact does cardiac safety have on your drug development planning or process? The results were 61% for a significant impact and 33% for a moderate impact. The audience for the event was comprised [...]
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Data from Emerging Markets is Questioned

Do clinical trials professionals, the ones that subscribe to our magazine and visit our website, monitor stock prices and the ups and downs of biopharm companies involved in drug development? I don’t know, if you do, let me know. I don’t get heavily into finances, but I do occasionally read Adam Feuerstein’s articles on TheStreet.com. He [...]
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Thoughts from CBI’s Oncology Drug Development Conference

As I mentioned a couple weeks ago, I was attending CBI’s Pharma/Bio Congress on Oncology Drug Development. The agenda was rich and the discussions very interesting. Being immersed in oncology for two days is not as depressing as it sounds, especially when you see how dedicated these experts are to their profession. The topics spanned biomarkers, [...]
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Oncology Forum Advances Dialogue

On October 24 and 25, I’ll be in Philadelphia attending CBI’s Pharma/Bio Congress on Oncology Drug Development . Since Applied Clinical Trials is a co-sponsor of the event, I will also be providing the opening introductions for the conference. And as an editor/observer of the world of clinical trials, I will offer some insights into what [...]
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Learn from the EU QPPVs

This Thursday at 9 a.m. EDT, Applied Clinical Trials is hosting “Understanding the New EU PV Regulations,” and you can register for this live event I spent an hour with the speakers going over the event on Friday, and they are very excited to be presenting on this topic.
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Did Someone Say Biotech?

Not just someone, but a lot of people. In conversations I’ve had with thought-leaders in the clinical trials space over the year, biotech companies are the place where growth will be seen for clinical trials. Even our own Advanstar Pharma/Science Editorial Director for Pharmaceutical Technology and BioPharm International Michelle Hoffman has indicated that biotech companies [...]
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