Accurate translation and strict quality control have become increasingly important as clinical trials become globalized. Therefore, the world’s leading pharmaceutical companies and CROs have chosen to partner with EC Innovations for reliable clinical document translation and language verification services. Clients have placed their trust in us to handle important clinical data and reduce the risk of translation quality for various clinical trial documents. Our team of professional medical translators and life sciences subject matter experts provide our clients with easy-to-understand, accurate, and regulatory-compliant translations for the smooth submission of results.
Services
Our areas of expertise include preclinical studies, clinical trial phases, regulatory applications, and pharmacovigilance. With an unwavering focus on quality, our team of language experts in the life sciences industry are well-equipped to provide translation services for various clinical trial documents:
- Clinical Trial Protocol
- Scales and Quality of Life Questionnaires
- Patient Safety Card
- Informed Consent Form (ICF)
- Patient Information Sheet (PIS)
- Patient Diaries and Electronic Diaries
- Investigator’s Brochure
- Case Report Form (CRF) and
Electronic Case Report Form (eCRF) - Clinical Trial Agreement
- Clinical Trial Authorization
- Serious Adverse Event Reporting
- Investigational Drug Label
- Ethics Committee Review Application
- Other clinical documents
Subject Matter Experts and Translation Teams in Specialized Areas of Expertise
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:
Subject matter experts (SME)
With a background in the field of life sciences and a wealth of experience and knowledge in clinical trial translation, SMEs provide support for terminology translation and maintenance, and answer questions raised by translators.
Outstanding translators
Identified through rigorous rating based on the Translation Quality Report (TQR), the same translators are assigned to the best of our ability, for projects on the same product line and for the same client.
Experienced proofreaders
With many years of clinical trial translation experience, our proofreaders are able to efficiently use cloud-based computer-assisted translation tools for real-time review and proofreading, providing feedback to translators in the shortest possible time.
Stringent reviewers
Reviewers have background knowledge of relevant clinical trials and they examine the translations through the eyes of the end-user, without referring to the content of the source document.
Quality assurance (QA) reviewers
The QA team samples 10% to 20% of the translations for individual quality review to identify possible quality issues.
Native reviewers or third-party reviewers
Upon request by the client, native-speaking or third-party reviewers will be brought in to further ensure translation quality.
Native language leads
Native language leads work closely with translator recruitment and project managers to assemble a custom professional translation team for each client.
Multilingual desktop publishing team
This team ensures that translated documents are compliant and can be published in the correct format.
ISO certification
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.
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.
Safety
Deeply aware of the significance of confidentiality in the life sciences industry, we are committed to ensuring the security, confidentiality, and integrity of all documents and communication. We follow strict confidentiality procedures and guidelines to safeguard customer data and information throughout the translation process, allowing our customers to rest at ease. We ensure that translation work fully complies with relevant safety procedures through a self-developed translation management system that covers the entire duration of the project cycle.
We appreciate your interest in EC Innovations.
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