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Tag Archives: Lisa Henderson
Take a Moment for the Patient
Late last month, CBI and Applied Clinical Trials hosted Patient Centricity in Clinical Trials, which included discussions on many aspects of clinical trials and how to put patients first so they feel more like valued participants in these trials. As the conference wrapped up, the final discussion included chronic disease patients with varying levels of [...]
Posted in Uncategorized Also tagged Carol Levy, CBI, Joseph Kim, Patient Centricity in Clinical Trials, patients, Shire, trigeminal neuralgia Leave a comment
When Oncology and Cardiac Safety Meet
Earlier this week, our blog Keeping up with Cardiac Safety featured slides I presented at the Cardiovascular Risk Assessment Summit at the end of January. We co-hosted the two-day event with CBI, our conference group, and it was full of very high-level scientifically-rich presentations, as well as conversations about the cardiologists and doctors in the [...]
Posted in Labs Also tagged Cancer, cardiac safety, CardioCore, CBI, ETASU, FDA, Labs, Lisa Hendrson, oncology, REMS Leave a comment
CV Assessments Set to Increase
Last week, I spoke at the 6th Cardiovascular Risk Assessment Summit and provided an overview of CV safety, challenges facing sponsors, and current trends.
Posted in Labs Also tagged 6th Cardiovascular Risk Assessment Summit, cardiac safety, CV assessments, ECG, Industry Standard Research reports Leave a comment
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 [...]
Posted in Uncategorized Also tagged Bioethics Commission, government funded research, NIH, President Obama Leave a comment
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 [...]
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 [...]
Posted in Sites Also tagged Craig Lipset, patient centered, patient recruitment, Pfizer, Quintiles, REMOTE, social media, subject recruitment Leave a comment
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 [...]
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 [...]
Posted in Regulatory Also tagged cardiac safety, CV, ERT, PPD, Rob Dow, Rober Kleiman, TQT Leave a comment
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 [...]
Posted in Uncategorized Also tagged Adam Feuerstein, China, emerging markets, FDA, India, RENAISSANCE, Targacept, thestreet Leave a comment
Hiring Up for CROs and Services