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.