Multilingual Clinical Trials
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
The EC Innovations Difference
EC Innovations Life Sciences has been an established leader in medical device translation for over 27 years. What sets us apart from the rest?
Qualifications and Standard Compliance
EC Innovations Life Sciences holds ISO 13485:2016 and ISO 17100:2015 certification for the translation and localization of the accompanying content for biotech and medical devices.
EC Innovations Life Sciences complies with high quality standards of the life sciences sector to meet end user’s expectations and patient safety. We are especially honored to be Siemens’ Outstanding Language Service Provider since 2007.
Dedicated Life Sciences Division
With focus and commitment comes professionalism, EC Innovations Life Sciences is a division with more than 100 employees dedicated to serving only the life sciences industry.
Innovative technologies (TBMS LPA) make continuous delivery possible
We’ve been continuously refining our TBMS LPA system more than 15 years ago to fit the business trends and compliance needs of our medical device clients. Our proprietary technology enables the workflow automation for content transfer, file preparation, instant quotation, maintenance of language assets, KPI evaluation, data mining for decision making, translation quality report generation, among others. This allows us to shorten turnaround time and lower cost without compromising quality, and make continuous delivery an achievable solution. Refer to TBMS LPA for more information.
Project Team as the Cornerstone of Quality
Our translation team mainly comprises native speakers of the target language who take on the following roles:
- Subject-matter experts (SME): Possessing medical background with cumulative experience and knowledge in medical translation, our SMEs support terminology translation and maintenance as well as answer technical questions from translators.
- Qualified translators: Our translators undergo assessment based on our Translation Quality Report (TQR), and we try our best to assign translators to the same product line for the same client.
- Experienced editors: With years of experience in medical device translation, our editors are effective at using our cloud-based Computer-assisted Translation tool to review and make edits in real time to provide feedback and confirmation in the shortest time possible.
- Rigorous proofreaders: Equipped with background knowledge of related medical devices, they simulate end users by reviewing the translation with a fresh eye and without referencing source content.
- Quality Assurance reviewer: Our QA team will sample 10% to 20% of total translations to independently verify quality and identify potential quality issues.
- In-country reviewers or third-party reviewers: Often requested by clients to serve as a further guarantee of translation quality.
- In-country language leader: Work closely with our translator recruitment and management team to build tailored and dedicated translator teams for each client.
- Multilingual DTP team: Ensure that translated documents are compliant and ready to be published in the right format.
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.
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The Best Quality-to-Cost Ratio on the Market.
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