 Alan Copa, PharmD Cetero Research President, Clinical Operations Visit Website |
Alan Copa is President of Cetero Research’s Fargo site. He has more than 17 years of CRO experience in a variety of clinical research roles including hands-on experience as a clinical study coordinator, director of pharmacy and director of clinical research.
Dr. Copa has a Doctorate degree from the University of Minnesota College of Pharmacy, Minneapolis, Minnesota. He is a member of the American Association of Pharmaceutical Scientists and the American Society of Clinical Pharmacology and Therapeutics.
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Cardiac Safety in Early Phase Q&A
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What considerations should be given to the collection of multiple measurements at the same time points?Answered May 31st, 2011 by Expert:In Cetero’s experience, when multiple measurements are to be collected at the same time point, the order of activities should be:
1. Holter ECG acquisition
2. PK sample collection
3. Vital sign measurementPriority should be given to the collection of the triplicate ECGs from the Holter device because of the amount of time required for the supine resting period prior to collection and the time associated with the actual ECG acquisition.
Typically, the ECG acquisition period is 10 minutes in length. Following completion of this 10-minute period, the PK blood sample should be collected. Finally, the vital signs can be collected in a supine position. The order of collection and time windows allowed for collection should be clearly outlined in the protocol.
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