- Cardiac Safety - Boaz Mendzelevski, MD - Medifacts International
- Drug Delivery Technologies - David M. Oakley, R.Ph., Ph.D. - AAI Pharma
- Imaging - Richard Walovitch, Ph.D. - WorldCare Clinical
- What unique skills are needed to manage the supply chain for controlled drug ...
Instead of terming this a skill set, I would recommend a project lead who is well versed in FDA, EMEA, and government regulatio... read more
Answered by: Tim Brewer - How is the use of visualization technology helping companies better communica...
Visualization technology supports the saying that "pictures are worth a thousand words." In today's environment where clinical t... read more
Answered by: Sean Smith, PhD - Why do you think there remains such poor enrollment in cancer trials, where s...
It is an often quoted fact that only a small percentage of people with cancer participate in clinical trials, despite there bein... read more
Answered by: Rick Malcolm - What are the one or two, in your opinion, most promising novel imaging techni...
In Phase I and Phase II studies, dynamic-contrast enhanced magnetic resonance imaging (DCE-MRI) has shown promise in studying th... read more
Answered by: Richard Walovitch, Ph.D. - Despite usually a lower number of patients, how challenging is the monitoring...
The monitoring burden per patient in oncology trials greatly exceeds that in many other indications. There is a large complex s... read more
Answered by: Lyon Gleich - The genetics of obsessive-compulsive disorder remain a mystery. Are researche...
Researchers are always getting closer to answers... read more
Answered by: John H. Greist, MD - How has FDA’s tighter requirements for assessing cardiovascular risk, parti...
The new diabetes guidance has reinforced the fact that cardiac safety has become the No. 1 reason for drug withdrawals and label... read more
Answered by: Jeffrey Litwin, M.D., F.A.C.C. - Are the benefits of integrating IVR systems with other study management tools...
Whilst such integrated services are relatively new to the industry, the acceptance of the concept and adoption of such integrate... read more
Answered by: Dr. Bill Byrom, Ph.D. - What advantages do microemulsion formulations offer specifically for topical ...
The term "microemulsion" often used to describe a variety of micellar structures from simple droplets to complex cubic compositi... read more
Answered by: David M. Oakley, R.Ph., Ph.D. - Are there any ways to ameliorate the cardiac risks of a drug in development, ...
Affirmative. There are several examples of drugs including antipsychotics and antiarrhythmic that had to be withdrawn from the m... read more
Answered by: Boaz Mendzelevski, MD - What added challenges do adaptive trials, where changes can be dramatic, pose...
Adaptive trials are a hot topic of discussion around Fisher Clinical Services these days as we are starting to see an uptick in ... read more
Answered by: Astrid Frank, Rph
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