About

What We Do

Providing Quality Assurance Expertise

Clear CQA was established in 2018 by Donna McElcar as a way to provide QA expertise directly to companies while ensuring dependability, high standards, and high-quality advice and deliverables. We collaborate with associates around the globe with extensive QA backgrounds to provide customized services to our clients.

Donna M. McElcar, MS, RQAP-GCP

President

Donna has been a quality assurance professional since 2001. She has an extensive and broad background working with small and mid-size CROs, a medical device sponsor company and as an independent consultant.

Her reputation for providing honest, easy to understand, and valuable quality assurance advice and deliverables stands for itself. Her company represents integrity, honesty, and dependability.

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Testimonials

What Our Customers Have to Say

"Donna is incredibly responsive, professional and highly knowledgeable in GCP quality auditing. She works at an incredibly high level and provides excellent auditing services to our organization."
M.P.
Biotechnology Company
"Donna has been working with our Clinical Research Company for the past several years. She audits our charts, gives recommendations for improving our CQ practices, and periodically reviews and works with us to revise our Company SOPs. She is always willing to come in on short notice to review charts or procedures and is available for phone calls or email consultation. We love working with Donna and would highly recommend her services."
C. A.
Research Institue
"Clear CQA has unparalleled expertise and knowledge in GCP compliance. Their team delves into the details to identify gaps and then formulates quality and efficient solutions that custom fit the complexities of our company. Whether we need procedural documents, training, audits, or answers to complicated questions, Clear CQA is our trusted compliance partner. "
D. R.
Contract Research Organization
"I had the pleasure of working with Clear CQA over a 2-year period starting in January 2020 while I was heading up the Clinical Quality Assurance group at a small biotech that heavily outsourced.

Her flexibility and willingness to provide whatever we needed as a small biotech was greatly appreciated. During the first half of 2020 when all audits were on hold, Donna was successfully able to pivot to provide valuable technical writing help. Her expertise was invaluable to us as we were revising our Medical Writing and Quality Assurance SOPs. She was able to apply her in-depth knowledge of auditing to her review of our draft audit templates and help us to bring them in line with industry standards.

In addition, she quickly adapted to remote auditing during the pandemic and we were able to complete a significant number of remote audits in 2020. As our book of work increased in 2021, she was able to recruit additional functional subject matter experts to serve auditors and consultants, remaining flexible with the scheduling of our multiple vendor, investigator site, internal and trial master file audits.

Throughout our working together Donna was consistently knowledgeable, flexible and always professional. I would recommend her services whole-heartedly to anyone who has need of a GCP Quality consultant or auditor. "
D.N.
Biopharmaceutical Company