Chapman Pharmaceutical Consulting, Inc. Chris Chapman, MD
Chapman Pharmaceutical Consulting, Inc. Chris Chapman, MD 

The Mission of Chapman Pharmaceutical Consulting is to help clients meet or exceed the worldwide quality and regulatory requirements, whether they involve compliance or product approval applications.

 

CPC is committed to contributing to society by helping to bring safe and effective health care products to markets around the world.

 

CPC is an S-Corporation in the state of Maryland. The corporation has been authorized to issue capital stock.

 

Chris Chapman, M.D., chairman of CPC is an international pharmacovigilance expert. He is also the chairman and founder of Chapman Pharmaceutical Health Foundation. CPHF.org is an IRS Section 501(c)(3) nonprofit organization established to solicit public funds and to support healthcare needs such as AIDS, diabetes, hypertension, lupus, sickle cell anemia, malaria and tuberculosis.

Good Clinical Practice Audits a Specialty

Chapman Pharmaceutical Consulting has highly qualified health and quality professionals with special skills, relevant knowledge, and decades of experience in conducting compliance audits for domestic and international clinical studies. We can provide a wide range of GCP regulatory auditing services tailored to your company's specific needs. We specialize in domestic and global GCP regulatory audits. These independent and objective third party audits are designed to ensure that all contracted services meet regulatory requirements. Our auditors are knowledgeable of the most up-to-date developments in GCP regulatory requirements including adverse event reporting obligations.

 

Compliance audits include a contracted work agreement covering:

Pre-audit review of the study protocol, case report forms, Investigators Brochure, Informed Consent Form, and other selected documents.

 

GCP audit plan one week before start of the audit.

 

Identification of principal and secondary sites to be audited.

 

Site audit metrics, e.g., number of case records examined for inclusion/exclusion criteria, presence of informed consents etc.

 

Daily audit Finding briefing for principal investigator or designee.

 

Written notice of significant observations at time of audit closeout.

 

Confidential comprehensive written final audit report covering all key GCP compliance requirements.

 

Compliance assessment of deficiencies most likely to result in regulatory action.

 

Independent assessment of significant findings by a physician safety officer, as needed.

 

Corrective action request (CAR) matrix identifying significant nonconformance, individual assigned responsibility for the corrective action, and a time line for completion of the corrective action.

 

FDA readiness training providing instruction on preparing for and managing an FDA inspection to successful outcome.

 

Other Chapman Pharmaceutical Consulting GCP services include:

Central laboratory audits including the tracking of clinical trail specimens from collection, laboratory analysis, and reporting to principal investigators.

 

Clinical supplies audits including auditing all aspects of clinical trial supplies in accordance with FDA, EU, and ICH requirements.

 

Institutional Review Boards including auditing against FDA and EU guidelines and regulations.

 

Adverse Event Reporting System Audits including auditing of the process for adverse event reporting against applicable regulatory requirements.

 

Final Study reports NDA Submissions, Safety Reports, IND Update Submissions including auditing and reconciliation of databases used to compile licensing applications.

 

Computer System Validation including auditing against FDA software validation requirements and Electronic Records and Signatures (part 11).

 

Training of health professionals in GCP requirements including hands on practical instruction on how to meet regulatory requirements.

 

Preparation of GCP policies, SOPs and Work Instructions.

Chris Chapman, MD

Founder and CEO

Chapman Pharmaceutical Consulting, Inc

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