ClinAudits
Overview
A professional auditing and consulting firm for researchers and biomedical manufacturing companies, ClinAudits, LLC, was founded in 1994 by Cheri A. Wilczek, a clinical research auditor with more than 30 years in the pharmaceutical industry. Prior to working as an auditor, Wilczek spent 10 years with the Upjohn Company as a biochemical quality assurance professional, having achieved her Master in Science from the University of Maryland. “As a provider of objective compliance audits and quality remediation solutions, ClinAudits is aware of the inconsistencies in the conduct of bioanalysis in support of current clinical trials,” Wilczek explains in a press release related to an expert working group. ClinAudits is dedicated to helping its clients uphold the highest standards in GCP, GMP, and GLP compliance and maintain compliance with all U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) regulations.
Offering assistance with both domestic and international regulatory standards, ClinAudits employs senior-level auditors in Europe, the U.S., and Canada. On average, ClinAudits’ auditors possess over 17 years of consulting field and auditing experience. Its stringent screening of potential employees allows ClinAudits to consistently provide the highest-quality examination and guidance to the sponsors of clinical trials. Serving over 400 clients worldwide, ClinAudits firmly adheres to standards of excellence in clinical auditing and consulting, the foundation of its reputation as a leader the field of contract research organizations (CROs).
While performing on-site audits for ClinAudits, each auditor must exercise solid problem-solving skills, independent and objective thinking, and strong interviewing and listening skills. By upholding the highest industry standards for its employees, ClinAudits ensures that every client receives a professional, congenial auditing experience, with demonstrated corporate, cultural, and political sensitivity.
In addition to consulting and auditing services, ClinAudits assists with a variety of related functions, including regulatory affairs, project management, monitoring, and medical writing services. Industry clients in pharmaceuticals, medical device design and manufacturing, tissue manufacturing, and biotechnology benefit from ClinAudits’ expertise.
ClinAudits commits to environmental responsibility in all aspects of operation and has transitioned to reading reports in electronic copy, eliminating the need for paper printing and reducing the company’s paper usage 47 percent. When the need for printing does arise, ClinAudits uses 100-percent recycled paper.