CROATIAN MEDICAL TRANSLATOR AND LINGUISTIC VALIDATION CONSULTANT
„Translation is that which transforms everything so that nothing changes.”
— Günter Grass
About Me
My name is Marina Zullo and I am a freelance medical translator and linguistic validation consultant. I hold a degree in English and German language and literature and have over 15 years of experience in the translation industry.
Why medical translations?
A word with me.
The secret sauce to a translation specialization is the love for the content you work with. My interest in life sciences reaches way back and it was a crossroads moment that made me pursue my education in linguistics, and not medicine. Today, I am happy to combine what I love the most: translating your ideas with an avid attention of a linguist while diving into the intricacies of various medical concepts.
Having worked on various demanding technical and legal projects throughout my career, I can also handle any highly technical or legal aspects of your documentation (such as product descriptions, agreements, etc.).
Let’s connect and see how I can help your business.
Linguistic validation
Trust your data, worldwide.
Your reliable partner for translating and culturally adapting COAs and eCOAs
As the number of clinical trials conducted worldwide rises, so does the need to translate the instruments that measure how the patients feel, function and survive in relation to the treatment they receive.
Such instruments include questionnaires intended for patients, clinicians or caregivers. Collectively, they are referred to as Clinical Outcome Assessments or COAs.
Patient-Reported Outcomes, or PROs for short, are increasingly recognized as the most valuable type of COAs in modern clinical trials because they capture patient experience directly from the patient’s perspective. They are filled in by patients themselves, and as such, require the use of low register clear language that any patient can understand.
During linguistic validation of COAs, we not only translate them, but also ensure they are conceptually equivalent to the source and culturally adapted for the target patient population. The process unfolds by implementing the methodology based on ISPOR, EMA, PRO Consortium and FDA guidelines to ensure regulatory compliance as well as data integrity and comparability worldwide.
As a linguistic validation consultant (LVC), I offer a comprehensive suite of services, including:
✔️ Translatability Assessment in the early stages of COA development
✔️ Reconciliation of forward translations
✔️ Back-translation analysis
✔️ Back-translation review, discussion and harmonization
✔️ Developer-review discussion
✔️ Cognitive debriefing
✔️ Cognitive debriefing discussion
✔️ LVC Review
✔️ LVC analysis of the external review
✔️ Final quality check
Translation
Translation / Localisation
Reaching international audiences involves more than simply translating. Your content will be adapted, both linguistically and culturally, so that it sounds like it was written in Croatian in the first place. This will make your product more appealing to the target audience, improve the effectiveness of your communication and bring you closer to your goal – which is the reader engaging with your content, gaining trust in your company or ultimately buying your product.
I am familiar with the specific demands that apply to clinical trial documentation, especially those presented to regulatory bodies for approval. By entrusting me with these sensitive documents I can help you stay on your schedule and avoid any unnecessary delays.
Editing
I will revise your already translated documents and ensure they are free of any omissions or additions, grammatical or spelling errors, that they are easy to comprehend and that their tone is appropriate for the target audience.
Proofreading
I will check the final version of your translated documents for consistency and accuracy before you publish them or present them to your target audience.
Documents I work with:
Clinical Trials
✔️Clinical Trial Agreements (CTAs) & Financial Agreements
✔️ Clinical Trial Protocols and Amendments
✔️ Cover Letters and other correspondence with regulatory authorities
✔️ Plain Language Summaries (PLSs)
✔️ Patient Information Sheets (PIS)
✔️ Patient Recruitment Materials
✔️ Informed Consent Forms (ICFs)
✔️ Investigator’s Brochures (IB)
✔️ Clinical Outcome Assessments (COAs): PROs, ObsROs, ClinROs and PerfOs
✔️ Patient Diaries
✔️ Marketing and advertising texts, and other
Regulatory Documentation
✔️ Summaries of Safety and Clinical Performance (SSCPs)
✔️ Summaries of Product Characteristics (SmPCs)
✔️ Patient Information Leaflets (PILs)
✔️ Product Labels
Medical Devices
✔️ Instructions for Use (IFUs)
✔️Technical Documentation
✔️ User Manuals
✔️ Software / Apps / Websites
Why work with me?
✔️ Regulatory Compliance: I ensure full adherence to regulatory guidelines by implementing best practice methodology for all your linguistic validation projects and regulatory submissions.
✔️ Subject-Matter Expertise: I provide medically and scientifically accurate translations.
✔️ Patient-Centricity: I ensure translations are culturally sensitive and easy for patients to understand.
✔️ Collaborative Partnership: You have direct access to a dedicated expert committed to providing clear communication and prompt responses.
Whether your target audience are paediatric or adult patients, healthcare professionals, casual readers visiting a doctor’s office or scrolling your websites, tech experts in charge of your devices or software, or regulatory body specialists, I will make sure to use the right tone, register and style to address them.
I am familiar with the specific demands of various document types, whether patient-facing or those presented to regulatory bodies for approval.
I keep to the highest standard of quality and support you every step of the way, making sure all your expectations have been met and any issues along the way quickly resolved.
In my workflow I don’t rely on any AI tools and your materials won’t be put through any machine translation engines, thus ensuring complete confidentiality. The translations are based on your instructions, my know-how and the use of correct terminology, as either recommended by health authorities or per your request.
Get In Touch!
I will review your documents and send you a non-binding offer, while ensuring complete confidentiality.
Send me a message
Location
Croatia