In order to gain further insight into the variety of our clients’ exciting industries and to share about challenges working in a global world CETRA presents Client Interviews. This interview features Patrice Pompa, Director of Contracts and Regulatory Services at CFS Clinical. CFS Clinical is a specialty provider focused on the business and financial management activities of clinical trials located in Audubon, Pennsylvania.
Please describe the industry you work in!
I work in the pharmaceutical clinical research industry at a CRO (Contract Research Organization) specializing in clinical study activation and investigator payments at CFS Clinical.
What is your favorite part about the industry you work in?
The opportunity to work on new projects and with new clients keeps things exciting.
What is a challenge you face doing business internationally?
Regulatory document management, for now, is just with U.S. sites. Our clinical investigator payments group does work globally. We use translation services to make payments in other countries.
How has working with a Language Service Provider made your job easier? How often do you use a Language Service Provider?
We could not provide clinical document translations on our own, so yes this has made our job easier. We use translation services for site IRB (Institutional Review Boards) approved Informed Consent and Assent forms. For individual studies, about 40-60% of U.S. clinical sites may request translated, and often back-translated, consent documents with notarized certifications. In general, we may request a translation at least once a month. Thus we must have a translation partner who can respond quickly to turn-around these requests within days.
What was one of your most memorable projects that required translation or interpretation?
There was a recent project where CETRA noticed a discrepancy in the English version of the informed consent during their translation process and brought it to our attention. Because of their scrutiny, we were able to get the site to make the correction, get it IRB approved again, and complete the translation within a short period of time.