Speaker Profile


Charles H Pierce

Consultant, Pierce One Consulting

Charles H. Pierce MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 48+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 27+ 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 2018). He is frequently actively involved in Webinars, courses and workshops giving the clinical investigator and staff an understanding and appreciation of the ethics as well as the science and regulations governing clinical research with drugs or devices. The end must be knowledge and keen observation to ensure drug safety. 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). From experience and practical know-how the special needs of these units (from the floor plans to operational SOPs) has been of added value to those considering this venture. He has work experience in Device Studies and Pharmacovigilance. The later (PV) is of special interest as Phase I through Phase III do not guarantee drug safety. Actually this vigilance must start with the very first studies in human subjects.

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) of which he was a Regent 1995-2000, Chairman of the 2001 annual meeting, and the 2004 recipient of the Nathaniel Kwitt Distinguished Service Award. He is an active member of the Association of Clinical Pharmacology Units (ACPU) of which he was a trustee (2007-2011) and chaired the successful 2010 annual meeting. 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).

No Live Webinars found.




  • Recorded
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  • 90 Minutes
  • ¤190.00
How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant

Deviations and Violations from the agreed upon protocol may very well affect the scientific validity of the research. For this reason, a well-written protocol, taking onto account the role of all the Inclusion and Exclusion criteria in subject enrollment is a key element in having deviation free study conduct.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤390.00
How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant

Deviations and Violations from the agreed upon protocol may very well affect the scientific validity of the research. For this reason, a well-written protocol, taking onto account the role of all the Inclusion and Exclusion criteria in subject enrollment is a key element in having deviation free study conduct.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤390.00
21 CFR Part 11 Compliance - Ensuring Data Integrity and Safety in Clinical Research

Electronic medical records and electronic handling of study data is increasingly common. To involve computer systems in clinical research implies knowledge of 21 CFR Part 11 (ELECTRONIC RECORDS; ELECTRONIC SIGNATURES) and all of the ramifications of this Part of the code is essential.

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