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English to Polish: Cover letter; clinical trial; fragment General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English Dear Sir, Dear Madam,
I would hereby like to submit the “Clinical Trial Authorization (CTA) Application” to conduct the aforementioned multinational clinical trial using sites in [country name] on behalf of our client, [company's name].
The documents in this “Application” have been prepared in accordance with the following European “Guideline” published in 2005 and as amended by the “Guideline” published in 2010:
“Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the Competent Authorities, notification of substantial amendments and declaration of the end of the trial (CT-1)” dated Mar 2010.
This “CTA Application” has undergone assessment via a Voluntary Harmonisation Procedure (VHP) involving [list of VHP-participating countries].
Translation - Polish Szanowni Państwo,
w imieniu naszego klienta, [nazwa firmy], chcielibyśmy złożyć wniosek o wydanie pozwolenia na przeprowadzenie wyżej wymienionego, międzynarodowego badania klinicznego w ośrodkach w [kraj].
Dokumenty dołączone do niniejszego wniosku sporządzono zgodnie z następującymi europejskimi wytycznymi, opublikowanymi w 2005 r. i zastąpionymi wytycznymi opublikowanymi w 2010 r.:
„Szczegółowe wytyczne dotyczące składanych do właściwych organów wniosków o wydanie pozwolenia na prowadzenie badania klinicznego produktów leczniczych stosowanych u ludzi, zgłaszania znaczących zmian oraz oświadczenia o zakończeniu badania (CT-1)” z marca 2010r.
Niniejszy wniosek o wydanie pozwolenia na przeprowadzenie badania klinicznego został poddany ocenie zgodnie z dobrowolną procedurą harmonizacji (VHP), której podlegają [lista krajów podlegających procedurze VHP].
Hello,
My name is Agnieszka Zaremba, and I specialize in medical translations, especially clinical trials. I hold a master's degree in English and a post-graduate diploma in journalism. I was born and raised in Poland, but I have lived in USA for 14 years. I started specializing in medical translations ten years ago, and it has been my passion and profession since then. I have worked for numerous translation agencies providing them with timely and quality translation services. Only last month, I completed reviews of over 20 thousand words of highly technical medical documents and translated approximately 30 thousand words of clinical trial related documentation. Please refer to my resume for a full list of my indirect clients. My other working areas include: business (general), finance (general), advertising, law (contracts), diplomas, college transcripts, personal documents (birth certificates, marriage certificates, divorce decrees, etc.). I am available seven days a week from 9:00 a.m. until 6 p.m. (MST). You can contact me at [email protected]. Prices negotiable; references available upon request.
Member since Jun '06
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