This site uses cookies.
Some of these cookies are essential to the operation of the site,
while others help to improve your experience by providing insights into how the site is being used.
For more information, please see the ProZ.com privacy policy.
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
Expertise 
Portfolio