Dr Charles H Pierce
Consultant, Clinical Research
Charles H Pierce is President of the virtual CRO Global Clinical Partners, Inc and Pierce One Consulting. From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal Investigator), Charles has an experienced based knowledge of the Clinical Research part of Drug Development.

He is an APPI/APCR Certified Principal Investigator (CPI in 2003 and recertification’s to 2016). He is actively involved in Webinars, courses and workshops.

Charles’ active management experience in the medical research industry gives him first-hand practical experience and knowledge to develop Phase I, IIa confined study Clinical Pharmacology Units (CPU’s). Charles is a Fellow and Life Member of the American Academy of Family Physicians and Emeritus fellow of the American College of Clinical Pharmacology (ACCP) and the 2004 recipient of the Nathaniel Kwitt Distinguished Service Award. He is an active member of the Association of Clinical Pharmacology Units (ACPU). He is also a member of the Academy of Physicians in Clinical Research (APCR) and the 2012 Chair of the Board to trustees of the Academy of the Association of Clinical Research Professionals (ACRP).
Upcoming Webinar
Live Sessions Not Found.
Recorded Webinar
Adverse Event Reporting Compliance; The Key to Safe Drug Development / Subject Safety
The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn why the single most important function of the Principal Investigator and the study conduct team is the awareness, assessment, and management of Adverse Events occurring during the conduct of clinical research with drugs or devices utilizing human subjects.
Recorded Session Get life time access for one participant with download option!

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?
When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. This talk, by a certified physician investigator, will go over the regulations in a user friendly way. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begin with “I agree”.<br/><br/>
Recorded Session Get life time access for one participant with download option!

Why is Liver Injury (DILI) the Most Frequent Reason for a Drug Being Pulled from the Market
Ferreting out which Investigational Medicinal Products (IMP) might cause significant liver injury is not an easy process partly because there is confusion about how to test for liver injury and part because these AEs are rare (in the 1:10,000+ area) or "idiosyncratic" in type so are not picked up in the usual drug development process testing. We all know that AE’s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/his charge but some are very rare so the Investigators must be ‘heads-up’. Add to this, the large number of "non-drug liver injuries, which easily confound the issue. To be forewarned is forearmed.
Recorded Session Get life time access for one participant with download option!

Why Pharmacovigilance (Phase IV) Trials are Increasingly Seen: Why they are Important and what they tell us?
FDA-mandated post-market studies are here. Phase IV studies are likely to be complex in design and large in scale (possibly 500,000 patients per arm), with exacting endpoints, and obligatory. The FDA appears to be abandoning a long-standing policy of negotiating post-market commitments with sponsors - and will now set mandatory objectives and timelines.
Recorded Session Get life time access for one participant with download option!

How to interpret and Use Laboratory Data to protect the Safety of Subjects in Clinical Research Studies
All Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.
Recorded Session Get life time access for one participant with download option!

FDA Regulatory Control of the Drug Development Process and Investigator Responsibility in the Process
When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begi n with "I agree".
Recorded Session Get life time access for one participant with download option!

SUBSCRIBE TO NEWSLETTER
Get industry updates and exclusive deals on offers!