Attention to Details that matter.
Spotting the differences makes a difference
For data integrity and accuracy.
Available study documents will be cross-examined, to ensure the fine-tuned study review.
UK/ Europe, US, and Far East. Travelling globally for on-site audits.
Our auditor(s) will visit non-English speaking countries.
But the audits will be conducted either in English or in Japanese, and the audit reports will be written in English unless otherwise agreed.
Therefore, the non-English-speaking or non-Japanese speaking sites need a translator/ interpreter to assist the auditor(s).
Usually, the English-speaking study monitors (CRAs) would be available from the study team to assist our auditor(s).
Our QA personnel/ auditor(s) have a wide variety of background, from first-in-human studies to observational studies of post-marketed products.
Experience with a small pharmaceutical company with a unique investigational medicinal product, or a global clinical research organisation with working staff in every continent, or somewhere in-between.
The CV(s) of the auditor(s) will be provided upon request based on the business agreement.
I would like to sincerely thank you for the observations that you have highlighted and shared with us for this investigator site audit, as well as the very constructive approach during the debriefing and in the finalisation of the CAPA plan. It was very helpful and much appreciated.
Senior Project Manager, an international Contract Research Organisation
Clinical Trial QA 