Because lives are at stake,
every translation must meet the highest standards.
Life sciences translation requires advanced medical knowledge, a thorough understanding of regulations such as Japan’s PMD Act, FDA, and EMA requirements, and rigorous quality controls.
EC Innovations assembles dedicated teams of translators with medical or pharmaceutical backgrounds
and reviewers with specialized expertise. Through a rigorous ISO 17100-compliant process, we deliver critical medical information worldwide accurately and promptly.
Our Solutions
Solutions
We translate documents for every stage of clinical development and regulatory review.
Clinical Trials
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Clinical Trial Protocols
■
Investigator’s Brochures
(IB: Investigator’s Brochure)
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Case Report Forms (CRFs)
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Informed Consent Forms
(ICF)
Regulatory Submissions
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Common Technical Documents
(CTD)
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Re-examination & Re-evaluation Applications
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PMDA, FDA & EMA Submissions
■
Periodic Safety Update Reports
(PSUR: Periodic Safety Update Report)
Scientific & Post-marketing
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Medical Publications
■
Product Information
■
Training Materials
■
Patient Information Materials
Quality Management
QUALITY ASSURANCE
01
Review by Physicians & Doctoral-level Experts
Our subject-matter experts have backgrounds in fields such as cardiology, oncology, and neurology,
and translate and review content for exceptional scientific accuracy.
02
Rigorous Quality Assurance to ISO 17100
Our Translation, Editing, and Proofreading (TEP) workflow uses multiple independent reviewers
to maintain accuracy and consistent terminology.
03
Advanced Security for Confidential Information
Our ISO 27001-certified information security management system and secure infrastructure protect
unpublished clinical trial data and new drug information.
Contact Us
Contact Us
We will recommend the right solution for your needs.
Get in touch for a no-obligation consultation.