SPC and PIL, clinical trial documentation, CT contracts, manuals for catheters and MR and CT devices

Interpretation service (5 days) during a Sanofi double blind study supervised by a FDA officer (University Hospital, Olomouc).
Interpretation service at a presentation of Dr. Rosenthal, president of INICC (International Nosocomial Infection Control Consortium) for teaching hospital doctors (University Hospital, Ostrava), with the participation of Baxter.
Interpretation services for events at Teva Pharmaceuticals (Opava) - manufacturing and acquisition themes.

- 15 years in medical/pharma xlation, PhD in Biochemistry, spent 7 years in a R&D lab, both parents MDs.
- Working routinely with EMA templates and EDQM and MedDra termbases
- I convey the message, not replace word by word - my texts are clear, crisp and easy to understand for the target audience
- Working as a simultaneous interpreter at medical conferences, I am in touch with the live medical community and their language

For more details about me, please see www.czechtranslation.services

I am a medical and pharmaceutical translator with experiences ranging from translation of medical records to medical publications.

I have been translating clinical trial agrements into Czech for 8 years (I am unable to list the clients as I have signed an NDA with the agency that I work on clinical trials texts for). In that time, I have also worked on study brochures, study drug documentation, correspondence with regulatory agencies, etc.

Volume 2015-2017
• Hospital patient reports for clinical trials – translation Czech > English from pdf documents:
22 projects, 45,000 words
• Pharmaceutical SPC and PIL – translation and proofreading Czech <> English:
20 projects, 82,000 words
• Other medical, clinical trial, regulatory, science translation:
11 projects, 23,300 words

Professional translator since 1985
Former rescue paramedic
All development stages from drug discovery to pharmacovigilance, including scientific papers
All types of clinical research documentation
Experience with major CROs: IQVIA/Quintiles, Parexel, ICON/PRA, PPD, Syneos, Labcorp/Covance
Feedback to client in case of errors/inconsistencies in the source text
Strict confidentiality, no outsourcing, no MT
High throughput: typically 5000 words/day

5 years in Roche (portfolio of oncology drugs): translation of SmPC, EMA and FDA related documents, press releases, summaries of clinical trials, scientific articles abstracts, leaflets, patient brochures, documents for internal use
Leram Pharmaceuticals: Instructions for Use, Labelling