Our team of medical translation experts are proficient in handling diverse content and formats for life science organizations. We provide customized, high-value medical translation services specifically designed for the life science industry, covering an extensive array of subject areas.
From pharmaceutical to biotechnology and CROs to health organizations, our medical translation team becomes a valuable partner throughout the entirety of your language project. Whether you need a certified translation of your clinical trials or interpretation of your medical conference, we have you covered in over 200 languages.
What is Linguistic Validation?
The clinical trial management process takes place during the drug development cycle. The clinical trials data is collected from trial participants on their abilities, feelings, and influences during the study. The collected data is assessed and measured by using a tool called clinical outcome assessments (COAs).
Prior to delivering your product(s) to the market, you must ensure the results of the COA are accurate and culturally appropriate to your target population. The Linguistic Validation process is the solution that ensured the language(s) are accurate and culturally appropriate capturing results of the clinical trials.
BioMedica’s global team of linguists with expertise in medical and clinical trials, project managers, and subject matter experts work within our linguistic validation process to deliver high-value, quality translations of clinical trials in many languages.
Steps in Linguistic Validation Process
STEP 1: Assess Project
Review all source documents.
STEP 2: Dual Forward Translation
Two independent translators with subject matter experience will translate the source document into the target language producing two translated versions. The two translators will discuss and review both translations and will jointly produce one translation, which is known as a harmonized translation.
STEP 3: Editing
A third linguists will edit the harmonized translation and work with the original translators providing changes to the translations.
STEP 4: Back Translation
To validate the accuracy of the harmonized translation, a native English translator will back- translate the harmonized translation into English. The project manager and/or client will review the back translation and approve or discuss and question the items in the back translation.
STEP 5: Reconciliation of Final Translation
To validate the accuracy of the harmonized translation, a native English translator will back- translate the harmonized translation into English. The project manager and/or client will review the back translation and approve or discuss and question the items in the back translation.
STEP 6: Linguistic Validation by Clinical Review and/or Cognitive Briefing
Clinical Review
The final translation will be reviewed by an in-country clinical expert specializing in the therapeutic area of the study. The clinical expert will propose clarifications and/or changes.
Cognitive Briefing
An added step in the linguistic validation process, which requires recruiting in country patients/participants, conducting surveys and interviews, and report responses and any recommendations.
Our Linguists are Highly Qualified
BioMedica Communications linguist have the following qualifications:
- Native proficiency in the target language
- Minimum of 10 years’ experience in translation
- Advanced degrees such as Masters or Ph.D.
- Professional background in the medical sector
- Accreditation from the American Translators Association and/or University Degrees in languages
Experienced Medical and Language Experts
- Translation by two highly qualified linguists with medical and regulatory expertise
- Editing by linguists with medical expertise
- Multilingual multimedia production, i.e., typesetting. formatting, etc.
- Quality Assurance Review
- Final pre-production proofing
- In-country language review
- Notarized certification attesting to the final translation
Experienced Medical and Language Experts
- Translation by two highly qualified linguists with medical and regulatory expertise
- Editing by linguists with medical expertise
- Multilingual multimedia production, i.e., typesetting. formatting, etc.
- Quality Assurance Review
- Final pre-production proofing
- In-country language review
- Notarized certification attesting to the final translation
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