Submission-Ready Clinical Trial Translation Services: Precision Across Drug Development Life Cycle
From First-in-Class Drugs to Generics & Biosimilars – All Aligned with FDA/EMA/PMDA/NMPA Standards
Solutions
Multilingual Clinical Trial Translation Services: Precision Translations Across 140+ Languages for Every Clinical Trial Phase
EC Innovations delivers end-to-end clinical trial translation services across 140+ languages, including full coverage of EMA’s 24 official languages plus 16 key Asian and emerging market languages such as Japanese (PMDA-compliant), Korean (MFDS-aligned), Simplified Chinese (NMPA requirements), Thai, Vietnamese, and Russian (EAEU standards).
Protocols
- Version-Controlled Protocols
- Case Report Forms (CRFs)
Patient-Centric
Materials
- Informed Consent Forms (ICF)
- Patient Information Sheets (PIS)
- Patient Diaries & Questionnaires
Regulatory Submissions & Compliance
- eCTD-ready Translations
- Investigator’s Brochure
- Clinical Study Reports (CSR)
- Clinical Trial Agreements (CTA)
- Ethics Committee Review Application
- Module 1 Regional Documents
Safety & Compliance
- SAE Reports & SUSAR Narratives
- DSUR/PSUR Translations
- Risk-Based Monitoring (RBM) Materials
- Pharmacovigilance Documents
- Investigational Drug Labels
Why Pharma Clinical Trials Demand Specialized Translation
One Mistake in Translation Could Delay Your Studies by Months — Here’s How We Prevent It
Clinical trial translations require meticulous accuracy and regulatory insight. Misinterpretation in protocols, patient materials, or regulatory documents can lead to costly delays or compliance risks. EC Innovations ensures translation integrity through ISO 17100-certified processes and a team of global linguists with deep medical expertise. Our end-to-end workflows are built around stringent quality checks and translation memory (TM) management, enabling clients to meet FDA and EMA expectations with confidence.
ICH-GCP-Aligned Expertise:
Specialized translators in pharma clinical documents (protocols, CRFs, patient diaries).
Validated glossaries built from FDA/EMA submission archives and industry standards
Regulatory-Ready Workflows:
Dual ISO 17100 & ISO 27001 certification, ensuring end-to-end compliance from translation to data security.
CAT tools with full audit trails for protocol amendments.
Risk Mitigation Focus:
AI-enhanced QA team for SAE reports, combining machine translation with validated glossaries and human expert-in-the-loop to achieve industry-leading accuracy in blind testing.
TMS – ECI Flow for managing the version control system for tracking changes across multilingual trial documents.
Ensure Your Clinical Trial Translations are Submission-Ready and Fully Compliant
Clinical Trial Linguists: Where In-depth Industry Expertise Meets Accurate Translation
EC Innovations’ Life Sciences Localization division is a business unit comprising more than 100 employees dedicated to the life sciences industry.Our translation team consists primarily of native speakers of the target language, who serve in the following roles:
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, ISO13485, ISO 27001, and ISO 18587 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 13485
ISO 27001
Language Verification and Cultural Adaptation
EC Innovations fully understands the importance of language verification and cultural adaptation in the clinical trial process. We focus on the language verification of clinical outcome assessments (COAs), patient-reported outcomes (PROs), and patient quality of life questionnaires (QOLs). We help CROs back-translate, culturally adapt, and coordinate patient responses to ensure accuracy and consistency across languages.
Effective Project Management
At EC Innovations we’re able to simultaneously save time whilst eliminating mistakes in your translation project. Our move towards automated processing has seen a gradual reduction in human involvement in the workflow. With this we eliminate human error and increase the overall accuracy of the translation process. EC Link takes care of automatic content fetching, workload analysis, quoting, billing, TM and terminology maintenance and much more. The optimized workflow handles all your translation and localization needs at a pace to suit your schedule.
What types of clinical trial documents do you translate?
We translate the full spectrum of clinical trial documentation, including protocols, CRFs, ICFs, CSRs, and regulatory submission documents for agencies like the FDA and EMA.
How do you ensure compliance with FDA and EMA regulations?
Our ISO 17100-certified processes and deep regulatory expertise ensure all translations meet the specific requirements of the FDA, EMA, and other major health authorities.
Do you handle translations for all phases of clinical trials?
Yes, we provide end-to-end clinical trial translation services supporting all phases, from early-stage trials to Phase IV post-marketing studies.
What is your quality assurance process for clinical translations?
We employ a multi-step QA process involving certified translators, subject-matter experts, and regulatory reviewers to ensure absolute accuracy and compliance.
Can you manage urgent translation requests for trial submissions?
Absolutely. We offer expedited services with strict quality control to meet tight deadlines without compromising on accuracy or regulatory compliance.
How do you handle complex medical and scientific terminology?
Our specialized linguists have advanced life sciences backgrounds and use validated, client-specific terminology databases to ensure consistency and precision.
What languages do you support for clinical trial translations?
We cover 140+ languages, including all 24 official EMA languages and key Asian languages like Japanese, Korean, and Simplified Chinese.
Are your translation processes secure for confidential trial data?
Yes, we are ISO 27001 certified, ensuring robust data security and confidentiality measures are in place for all client documents.
What makes your clinical trial translation different from general medical translation?
We combine deep pharma clinical expertise with stringent regulatory knowledge, specifically tailored for the complex requirements of global clinical trials and submissions.
How can I start a clinical trial translation project with EC Innovations?
Contact us for a free consultation and compliance audit. We’ll analyze your needs and provide a tailored project plan with timeline and quote.
INSIGHTS
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