Precision Clinical Trial Translation: Accelerating Global Medical Research
Ensuring regulatory compliance and patient safety with specialized clinical trial translation services for protocols, ICFs, and CRFs.
INDUSTRIES
Precision Where It Really Matters for Life Science Translations
Nowadays, many clinical trials are conducted globally and language services are becoming an indispensable component of clinical trial processes. EC Innovations Life Sciences has been providing medical and clinical research translation services to clinical research organizations (CRO), sponsors, IRB, and hospital systems since 1997. We offer accurate, consistent, and comprehensible translations that meet all regulatory and local standards. Translations of materials include Patient Information Leaflets (PIL), Clinical Studies, Protocols, Doctor and Patient Guides, and more.
EC Innovations has been working with many of today’s leading companies in medicine and the clinical trial Industries for over 27 years.
Complete Translation Solutions for Multilingual Clinical Trials
Our expertise covers pre-clinical studies, clinical trial phases, regulatory submissions, and pharmacovigilance. With our main focus on quality, our dedicated Life Sciences linguist teams provide translation services for clinical trial materials that include:
- Study Protocol
- Case Report Forms (CRFs)
- Clinical Outcomes Assessment
- Protocol Synopses
- Patient Diary
- Investigator Brochures
- Patient Records
- Serious Adverse Event Reports
- Informed Consent Forms (ICF)
- Patient Questionnaires
- Ethics Committee Submissions
Ready to Ensure Compliance and Patient Safety in Your Global Trials?
Linguistic Validation and Cultural Adaption
EC Innovations Life Sciences understands that linguistic validation and cultural adaptation are essential parts of the clinical trial process. We specialize in linguistic validation of Clinical Outcome Assessments (COAs), Patient Reported Outcomes (PROs), and Quality of Life Patient Questionnaires (QoLs). We help CROs perform back translations, and cultural adaptation and harmonization of patient responses, to ensure accuracy and consistency across languages.
Confidentiality & Security
EC Innovations understands the sensitivity of clinical trials and research documents – all our clinical trial translators and experts work under binding non-disclosure agreements. Project managers monitor each translator’s work to ensure full compliance with the relevant security procedures. We are fully aware of the importance of confidentiality in the life sciences industry and take all necessary measures to protect the confidentiality of your documents and of any information communicated to us.
Strengths
Why 200+ Global Brands Choose ECI for Clinical Trial Translation
EC Innovations vs. Typical Localization Providers
| Comparison Criteria | EC Innovations Advantages | Typical Provider Limitations |
|---|---|---|
| Regulatory Expertise | ✅ Specialized teams familiar with FDA, EMA, PMDA requirements | ❌ Limited understanding of specific health authority guidelines |
| Quality Assurance | ✅ Triple-check system with medical SME review + ISO-certified processes | ❌ Basic review processes without subject matter expert involvement |
| Technology Integration | ✅ Advanced translation memory and terminology management systems | ❌ Outdated or limited technology infrastructure |
| Turnaround Time | ✅ Efficient workflows capable of handling urgent trial timelines | ❌ Rigid schedules unable to accommodate trial urgency |
| Data Security | ✅ Compliant with HIPAA, GDPR, and clinical trial data protection standards | ❌ Insufficient data protection measures for sensitive trial information |
About EC Innovations
EC Innovations is a global leader in life sciences translation, providing specialized clinical trial translation services to pharmaceutical and biotech companies worldwide. Our team combines medical expertise with advanced translation technologies to ensure your clinical documents meet the highest standards of accuracy and compliance.
Subject Matter Experts and Translation Teams in Clinical Research
Our specialized team includes medical doctors, PhD researchers, and regulatory affairs specialists who work alongside professional translators to deliver accurate, compliant clinical trial translations that maintain scientific integrity across all languages.
TEAMS
Subject-matter experts (SMEs)
With appropriate industry backgrounds,meet SMEs with extensive experience of document translation. They support terminology translation and maintenance while answering any technical questions translators may have.
TEAMS
Qualified translators
All our translators receive thoroughgoing assessment based on our Translation Quality Report (TQR). We also take the trouble to match translators to particular clients and product lines, to see that their knowledge of your business – and hence their utility on your projects – is always growing.
TEAMS
Experienced editors
With years of experience in document translation, EC Innovations’ editors use our cloud-based Computer-assisted Translation tool to review and make edits in real time. Generating feedback and approvals in the shortest possible time-frame.
TEAMS
Exacting proofreaders
Background knowledge in the relevant field allows our proofreaders to play the part of end users. They always review translations with a fresh eye, and without reference to source content.
TEAMS
Quality assurance reviewer
Our QA team samples 10% to 20% of total translations. Clients get independent verification of quality – and immediate identification of any issues.
TEAMS
In-country reviewers or third-party reviewers
Always available on request to serve as further guarantors of translation quality.
TEAMS
In-country language leaders
These key individuals work closely with translator recruitment and management to build dedicated teams of translators for each client.
TEAMS
Multilingual desktop publishing team
Readying translated documents for publication in the correct format, to ensure compliance.
CERTIFICATION
ISO Certified
We are one of the few language service providers in the world that holds ISO 9001, ISO 17100, ISO 27001, and ISO 14001 certifications.
We attach a high degree of importance to the delivery and quality assurance process of translation services. For EC Innovations, providing quality services has always been the guiding force behind our corporate values and beliefs. We do this by implementing rigorous and comprehensive quality assurance procedures, following comprehensive guidelines and checklists embedded throughout the entire project lifecycle. Tasks with substandard results will be reworked until the required quality level is achieved.
ISO 9001
ISO 17100
ISO 27001
ISO 14001
ABOUT US
Leading Pharmaceutical, Biotechnology, CRO, and Healthcare Organizations Trust Our Expertise
At EC Innovations, we specialize in delivering customized life sciences translation services at scale. Don’t just take our word for it—hear what our clients say about the impact of our expert life sciences translation services on their global projects.
What types of clinical trial documents require professional translation?
Virtually all documents do, but the most critical include Informed Consent Forms (ICFs), clinical trial protocols, Case Report Forms (CRFs), Investigator Brochures (IBs), and Patient-Reported Outcome (PRO) measures. Accurate clinical trial translation of these documents is non-negotiable for patient safety, data integrity, and regulatory approval across different regions.
How do you ensure translations are acceptable to global health authorities like the FDA or EMA?
Our process is built for compliance. We use subject-matter experts who are familiar with the specific terminology and guidelines of authorities like the FDA, EMA, and PMDA. All translations undergo rigorous linguistic validation and quality checks against these standards before delivery.
What is your turnaround time for translating a typical clinical trial protocol?
While timelines depend on the document’s complexity and length, our optimized workflows and specialized teams allow us to deliver high-quality translations significantly faster than industry averages. We prioritize urgent project requests to keep your Multilingual Clinical Trials on schedule without compromising accuracy.
How is the confidentiality of our clinical data guaranteed?
Data security is paramount. We comply with HIPAA, GDPR, and other stringent clinical data protection regulations. Our secure, encrypted platforms and strict confidentiality agreements with all staff ensure your sensitive trial information remains completely protected throughout the clinical trial translation process.
Do you work with rare language pairs?
Yes. Our global network includes native-speaking linguists and medical experts for over 200 language pairs. We have the capability to handle even the least common languages, ensuring your trial can reach diverse patient populations worldwide.
What is linguistic validation and why is it critical for PROs?
Linguistic validation goes beyond simple translation to ensure that patient-reported outcome (PRO) instruments are conceptually equivalent across cultures and languages. It involves rigorous steps like forward/backward translation and cognitive debriefing to guarantee that questions about quality of life or symptoms are understood identically by all patients, which is crucial for valid trial data.
Can you handle the translation of electronic Clinical Outcome Assessments (eCOAs)?
Absolutely. We have extensive experience localizing eCOA platforms and the associated content. Our team ensures that the digital interface, instructions, and assessment items are all accurately translated and culturally adapted for a seamless user experience in Multilingual Clinical Trials.
What qualifies your translators to handle complex medical and scientific content?
Our translators are not just language experts; they are specialists. Our team includes professionals with advanced degrees in life sciences, medicine, or pharmacology, coupled with years of specific experience in clinical trial translation. This dual expertise is essential for handling complex terminology and concepts.
How do you manage consistency in terminology across large, multi-phase trials?
We utilize advanced technology, including translation memory systems and client-specific termbases. This ensures that every term—from specific drug names to medical conditions—is translated consistently across all documents and throughout the entire lifespan of your trial, maintaining data integrity.
What is the first step to starting a clinical translation project with EC Innovations?
Simply contact us for a no-obligation consultation. We’ll discuss your specific trial needs, target languages, and timelines to provide a tailored plan and a transparent quote. Getting your clinical trial translation right from the start is the fastest path to global regulatory success.
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Need precise clinical trial translation? Contact our specialists today for compliant, accurate translations that ensure patient safety and regulatory approval across global markets.
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