SERVICES > TRANSLATION > CLINICAL TRANSLATION
Accurate & Reliable Clinical Translation Solutions
Clinical research and pharmacovigilance shape global health, but success depends on clear and accurate communication. At BIG Language Solutions, we do more than translate. We collaborate with sponsors, CROs, and regulatory teams to manage complex projects, ensuring your content communicates clearly and meets compliance and patient safety standards. We are proud to provide clinical translations for trials, research, and labels in the US, EU, and beyond.
Why Choose BIG Language Solutions?
Accuracy & Compliance for
Clinical Trial Translations
quality and security standards for compliance with regulatory bodies like the EMA, EU MDR, and the FDA.
Industry Expertise
You Can Rely On
BIG has a deep-rooted expertise in clinical research translation. Our linguists follow strict ethical, safety, and regulatory standards to deliver accurate, patient-safe translations that support every stage of the clinical trial process.
Accredited for
Quality & Compliance
BIG operates under a robust quality management system, holding ISO 9001, ISO 17100, and ISO 27001 certifications. Our commitment to quality, security, and compliance ensures your clinical trial and pharmacovigilance translations meet regulatory and industry standards.
End-to-End Project Management
Our fully managed translation service takes the pressure off your team. We handle deadlines, proactively manage projects, and ensure compliance with regulatory requirements, so you can focus on bringing new treatments to market.
Ready to Trust Every Word?™
Contact us today to learn how BIG Language Solutions can provide accurate, fast,
secure, and compliant translations for clinical trials and pharmacovigilance.
How We Can Help
Specialized Translations for Clinical Trials
and Pharmacovigilance
accuracy, compliance, and clarity in every clinical document translation.
Tailored Translations
for Every Audience
Patient-Facing Materials
Clear, accessible language for trial participants and patients.
- Informed Consent Forms (ICFs)
- Lay Summaries
- Patient/Doctor Information Sheets
- Appointment Reminders
- Drug Labels
Physician-Facing Documents
For physicians, researchers, and trial administrators.
- Clinical Study Protocols
- Investigator Brochures (IBs)
- Ethics Committee Letters
- Case Report Forms
- Clinical Outcome Assessments
Translation of Essential Documents
for Clinical Research
Clinical Research Documents:
- Protocol Synopses
- Instructions for Use
- Investigators’ CVs
- Adverse Event Reports (AERs)
- Patient Diaries & Questionnaires
- Interim/Final Reports
Supporting Documents:
- Drug labels & Inserts
- Literature abstracts
- Discharge summaries
- Electronic Patient Reported Outcomes (ePROs)
- Quality of Life (QoL) Instruments
- Clinical Outcome Assessments (COA)
How We Do It
Faster, Smarter, & Secure Clinical Translations
BIG Language Solutions eliminates delays, ensures compliance, and delivers accurate translations tailored to your clinical trial needs.
Get Started Instantly
Our deep life sciences expertise ensures immediate project kickoff. With extensive experience in clinical trials and regulatory translations, we streamline timelines and create efficient workflows to get you up and running faster.
Fast, Accurate, &
Compliant Translations
Our tech-enabled workflows keep clinical trial translations both fast and accurate. Human specialists oversee every step, ensuring regulatory compliance while cutting turnaround times by up to 3X.
Custom Solutions for Your
Clinical Translations
Our proprietary NMT engines are trained using industry-specific data, ensuring accurate translations for clinical letters, case narratives, and adverse event reports. All translations are backed by AI-enabled Quality Estimation. Our secure platform keeps your sensitive data fully protected.
“Our reviewers complimented the translations you did. Our Romanian reviewer said it was one of the best they had ever reviewed.”
Regulatory Affairs Associate
Global Clinical Research Organization
Translation Technology
LanguageExpress™
Fast, Secure, & Intelligent Translations
LanguageExpress™ is our fastest custom workflow that combines tech-enabled efficiency with expert oversight to deliver secure, high-quality translations for clinical research and regulatory compliance.
Neural Machine Translation (NMT) optimized for clinical and regulatory documents
Custom-built translation engines trained on your specific terminology and industry data
Seamless API integration with existing workflows for faster turnaround and reduced costs
ACCREDITATIONS & ASSOCIATIONS
BIG Language Solutions’ Professional
Certifications & Memberships
FEATURED
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The Importance of Translation to the Medical Device Market
In a recent article for MedCityNews, M&A specialist David Magnani outlined the top 7 challenges facing the medical device market. The global medical device market
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See how BIG can work for your business
Need expert language access solutions for your business?
From translation and interpretation to alternate formats and global compliance, we’ve got you covered.
Contact us today to see the difference BIG Language Solutions can make.
