Case studies

Life Sciences

Medical Interpreting for PMDA inspections

Our client is a leading full-service Contract Research Organisation (CRO) specialised in conducting clinical trials in multiple therapeutic areas across 50+ countries.

Omnicis was approached to provide Japanese interpreting services for two regulatory inspections taking place in Europe and USA.

The Challenge

As part of a drug application dossier from a leading pharmaceutical giant, Japanese inspectors from the Pharmaceuticals and Medical Devices Agency (PMDA) were required to verify conformity of clinical trial data with Good Clinical Practice standards (GCP). Given the complex nature of these inspections, our client’s sponsoring company required assistance from highly-skilled interpreters who were already familiar with these types of audits and well-versed in clinical trial terminology. The sponsor company also insisted on working with the same team of Japanese interpreters during the 2-day visit in Austria and the 2-day inspection in the West Coast.

The Solution

Drawing on years of experience in medical interpreting, our vendor team had no trouble in finding the perfect match in our extensive network of Japanese interpreters. The selected team had a proven track record in pharmaceutical audits such as Investigator's Meetings and PMDA inspections carried out in the UK and overseas.

As part of our standard recruitment process, all our linguists sign a NDA and confidentiality agreement prior to starting any work with us thus ensuring that all information received during these important meetings remain strictly confidential.

As each inspection assignment is different, it was important to share the agenda and all available documentation – in this case 100s of pages in Japanese and English – with our interpreters so they could familiarise themselves with the application dossier. This was done through a secure platform while we took care of the admin and travel arrangements for the sponsor’s peace of mind.

The Outcome 

Our client was most impressed with our team’s knowledge of the inspection process as well as their thorough level of preparation, which all contributed to the successful completion of both inspection visits. We have been providing the same level of service to this client from Western Europe to Latin America since 2014.

Get in touch with Omnicis to find out how we can help with your next audits or inspection visits.


To date, we have turned to Omnicis on several occasions, including an investigators' meeting and a couple of very important regulatory inspections. Every event they have serviced so far, since our first business in 2014, has strengthened our choice. We can wholeheartedly recommend Omnicis to anyone looking for quality interpreting services. PSI CRO


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