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

PILs, PROs, PIMs, SCALES, eCTDs, DFUs, Registration Dossiers for Medicines (SmPCs, packaging texts), Clinical Trial Protocols and Informed Consent Forms, Instructions for Use (IFUs), Case Study Report Forms, Clinical Study Report Forms, Patient Diaries, Preclinical - Phase IV Documentation, Case Report Forms (CRFs), Patient Guides, Patient Questionnaires, Doctor Guides, Investigator Brochures, Synopses, Training Documentation, CMC documentation, Medical Software...

I have a university degree in Biology, and I am an ATA-certified English-Spanish translator, with over 20 years of experience translating clinical trials, clinical research, nonclinical toxicology study reports, SAEs reports, investigator brochures, protocols, case report forms, product profile testing, toxicity reports, health, health care, pharmaceuticals, drug safety, user manuals, informed consents, patient information leaflets (PILs), SmPCs, disease management, safety data sheets (MSDS)

I worked for 10 yrs. (2003-13) at the Reg. Affairs and QA Dept. of J&J Medical Italy, where I gained extensive knowledge on MDs, QMS, and pharmacovigilance. I was involved in the In-country Review of MD IFUs and labels translated by external agencies, and I provided EN>IT translations of FSNs and FSCAs. This experience allowed me to acquire a regulatory mindset. My EN>IT translation of a book on bariatrics is pending publication. Since 05/13, I’ve been translating CT-related documents.

M.Sc.in biophysics, Ph.D.in biochemistry
I work for leading translation agencies translating such documents as:
» registration dossiers
» clinical trial protocols
» drug safety reports
» summaries of product characteristics (SPC)
» user manuals for pharmaceutical lab. & medical equipment
» interfaces for pharmaceutical software
» marketing brochures
» IFUs
» lab reports
» packaging and labels
» informed consents
» patients diaries
» questionnaires

I have translated over 30 pharmaceutical documents per year in the past 12 years. I have over 20 years of translation experience and an ATA Certification.

» health and well being campaigns
» health-related benefits and diet programs
» health insurance plan information
» end-of-life videos for patients and families
» data sheets on chemicals and health exposure
» application and use medication and cosmeceuticals
» reports on pharma studies
» toxicity reports on animal studies
» articles for medical journals
» user manual for small procedures and clinical analyses
» personal documents, including patient's records and death certificates

Traduction et relecture de documents tels que rapports d’hôpital, dossiers d'Autorisation de Mise sur le Marché, RCP (SmPC), notices techniques, documents de pharmacovigilance, essais cliniques, questionnaires ...
Correction d'articles scientifiques rédigés par des non-natifs.
Traductrice certifiée par l'Institute of Translation and Interpreting.
Membre de la Société Française des Traducteurs (SFT).
Co-organisatrice du séminaire d'anglais médical à
l'Université de Lyon.

A former Wikiproject Medicine Language Owner, still contributing to this portal
* Clinical trials
* Medical equipment
* Patient information

Some companies and brands:
* Roche
* Sysmex
* BioFire / bioMérieux
* Carl Zeiss
* Intersurgical

With 15 years expce writing and translating medical documentation, regulatory and medical communication, I am qualified at Masters level in Biology and worked as a BioEngineer for two years. I translate protocols, informed consent, patients diaries, interfaces for patients data consolidation software and marketing authorizations (inc. SmPCs) for the EMA. Most of my work has taken place in the following areas: oncology, psychiatry, and rheumatology. I am also a medical writer & editor.

I have been a full-time medical/pharma translator since 2002 (M.Sc. in biology). I specialise in clinical trials (study protocols, ICFs, IBs, EC/IRB correspondence etc.) as well as in SPCs and PILs. I also work in the field of medical devices, IFUs, patents, and other life science materials.
I have been working with agencies, therefore I am forbidden to name my end clients due to NDAs.

Clinical trials, research protocols and associated material, summaries of product characteristics (SmPCs), patient information leaflets (PILs) and consent forms, questionnaires, packaging leaflets, marketing tools, press releases, packaging, standard operating procedures (SOPs), quality assurance processes, safety datasheets (MSDS/SDS), etc.

Unbeatable mix of background (Molecular Biology & Biochemistry), experience, industry exposure (worked for major IT and pharma companies worldwide in a former life), technical skills (I built up my own high performance TenT including forefront CAT tools , e-dictionaries etc.), and language competences (ATA-Certified).
Millions of words translated for clients based in all 5 continents since 2005 as a full-time, independent translator.
My terms are carefully hand-picked, always!

Medical/scientific documentation (scientific articles, lab reports, lab manuals, etc.)
Devices, Pharmaceuticals, Surveys and Clinical Trials, Informed Consent Forms, Clinical Trials Agreements and Letters, Adverse Event Summaries, Medical Device Information, Lab Reports, Tender documents: Drugs and Drug sundries, Category B Clearance for Operational Unit of Nuclear Medicine: requests for clearance or updates to modifications on activities of Nuclear Medicine, etc.

Experience and Work History Since 1996: ◆ full-time freelance certified translator
I am registered as a Professional Translator at the Chamber of Commerce of Padua (Italy).
I am an Arabic-native freelance Translator based in Italy. Also I provide simultaneous and consecutive interpreting
Specialized in Finance, technical, pharmaceutical , and marketing texts.
I have worked for many companies over 1,000,000 words
I have a degree in Italian and translation
Sdl 2019, MemoQ

I have been translating medical and pharmaceutical documents for more than 30 years.
I first started working in pharmaceutical laboratories as a member of the team performing clinical studies follow-up, so it was a hand-on experience as well as, apart from translating all the materials, I was working with physicians and CRAs on all the different aspects of the clinical trials and this experience has been very useful when I decided to work as a free-lance translator.

Having a D.D.S degree since 1985 helped me understand the medical terminology. I have worked for over 11 years in translating clinical studies, patients' questionnaires and information sheets about medical equipments. I work on a regular basis for two big hospitals in the US translating all their written and online material for their Arabic speaking patients.

I am a veterinarian and have taught chemistry in high schools and at university entrance level.
I have worked as an English-Spanish interpreter at many international congresses at which pharmaceutical companies have presented products.
I translate from Eng to Sp. for Transperfect and have translated texts relating to all stages of drug approval for this agency.
I translate for several veterinary pharmaceutical companies, Merck, Boehringer, Rosenbusch Arg

I am 16 years of pharmaceutical domain translation.
Most of my experience is translating pharmaceutical patents which means a state-of-the-art content, new terminologies and recent techniques and pharmaceutical drug development
Also, I have a very good experience in translating pharmaceutical PILs, as well as translating clinical trials for many investigational drugs.
My M.Sc. and Ph.D. research studies helped me more in my translation experience.

I have much experience in translating medical records (e.g. past history, complaints, diagnoses/symptoms, imaging findings, medications and discharge summary), patient questionnaires/surveys, adverse events of clinical studies, etc..

Nonclinical toxicology study reports, pre-clinical safety profiles, fertility and embryo-fetal development study, PK data, PD data, treatment emergent AE’s, treatment related toxicity, safety summary, response summary, ICF/PIS, SUSAR, SAEs reports, CIOMs, investigator brochures, protocols and protocol amendments, case report forms, lab manuals, e-diary instructions, imaging guideline manuals, annual safety reports, initiation visits, medical monitor visits, sponsor audits.

I have been translating/proofreading pharmaceutical documents since 2009 and have extensive experience with clinical trial documentation (Clinical Trial Agreements, IBs, Study synopsis and design, ICFs, regulatory approvals), patient diaries, SPCs, PILs, questionnaires, IFUs, user manuals and software interfaces for medical devices, SOPs, brochures, packaging and labelling, medical reports.

Medical translation is serious business. Mistakes can be a matter of life or death. As such, it requires a keen focus on accuracy and terminology. And I deliver exactly that.
I have 15-year translation experience and medical education so whether you are submitting dossier for pharmaceutical registration, localizing software, translating clinical trial materials or documentation for global sales of medical equipment I can produce localized medical documents of the highest quality on the market.

- SOPs (Standard operating procedures), and patient information leaflets/Consent Forms
- Protocols
- Dosing diary description
- health and well-being campaigns
- health-related benefits and diet programs
- health insurance plan information
- data sheets on chemicals and health exposure
- application and use medication and cosmeceuticals
- reports on pharma studies
- safety data sheets
- Clinical trials: ICFs, patient diaries, subject recruitment mater, clinical trials agreements

I deal mainly with the translation and linguistic validation of Clinical Outcomes Assessments (COAs) and Patient Reported Outcome (PRO) questionnaires, acting as language validation coordinator for Italy.

My work includes also ranslation and proofreading of ICFs, user manuals of medical equipment and surgical instruments and the adaptation to QRD templates, translation and readability user tests of PILs and SmPCs.