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 years.

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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:

  • Clinical Trial Protocols and Amendments
  • Scales and Quality of Life questionnaires
  • Patient Safety Cards
  • Informed Consent Forms (ICF)
  • Patient Information Sheets (PIS)
  • Patient Diaries and eDiaries
  • Investigator's Brochures
  • Case Report Forms (CRF) and eCRF
  • Clinical Trial Agreements
  • Clinical Trial Authorizations
  • Serious Adverse Event Reports
  • Investigational Drug Labels
  • Ethics Committee Submissions
  • Other Clinical Documents

The EC Innovations Difference

EC Innovations Life Sciences has been an established leader in medical device translation for over years. What sets us apart from the rest?

Qualifications and Standard Compliance

EC Innovations Life Sciences achieved ISO 13485:2016 and ISO 17100:2015 certification in translation and localization of accompanying content for clinical trial industry.

EC Innovations Life Sciences complies with high quality standards of the life sciences sector to meet end user’s expectations and patient safety.

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 have been continuously refining our TBMS LPA system 15 years ago to fit the business trends and compliance needs of our clinical trial 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 life sciences background with cumulative experience and knowledge in clinical trial translation, our SMEs support terminology translation and maintenance as well as answer queries 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 clinical trial 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 to translators in the shortest time possible.
  • Rigorous proofreaders: Equipped with background knowledge of related clinical trial, 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 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 project manager to build tailored and dedicated translator teams for each client.
  • Multilingual Desktop Publishing 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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