- Accelerated Proof-of-Concept - Graham Wood, PhD - Cetero Research Clinical Operations Services
- Cardiac Safety in Early Phase - Alan Copa, PharmD - Cetero Research
- Drug Delivery Technologies - David M. Oakley, R.Ph., Ph.D. - AAI Pharma
- Imaging - Richard Walovitch, Ph.D. - WorldCare Clinical
- Patient support programs - Scott Dulitz, MBA - United BioSource Corporation
- 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 - With evidence showing that women are at a higher risk than men for proarrhyth...
The ICH-E14 guidance does indeed call for an "adequate representation" of female subjects in clinical trials, although not speci... read more
Answered by: Sean Smith, PhD - You mentioned patient adherence, which is currently a topic of major interest...
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. - Can you explain the logistical challenges of staggered dosing across cohorts?
Execution of an accelerated proof-of-concept study presents logistical challenges including: • Dosing as many as thre... read more
Answered by: Graham Wood, PhD - 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. - A student asks, "How feasible is the nasal route to deliver peptides into the...
Leave it to a student to ask a really hard question! The difficulty of the question lies in fact that it is actually multiple qu... read more
Answered by: David M. Oakley, R.Ph., Ph.D. - With evidence showing that women are at a higher risk than men for proarrhyth...
The ICH-E14 guidance does indeed call for an "adequate representation" of female subjects in clinical trials, although not speci... 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 - What considerations should be given to the collection of multiple measurement...
In Cetero’s experience, when multiple measurements are to be collected at the same time point, the order of activities should ... read more
Answered by: Alan Copa, PharmD
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