What is Back Translation?
Back translation is a critical part of the translation quality assurance process and seeks to validate translation accuracy. In back translation, a document that has already been forward translated is given to an independent translator (who has never seen the original text) to translate the document back into the original language. After back translating the document, if there are major discrepancies between the two versions, the reconciliation process is initiated: a report of all inconsistencies between the forward and back translations are compiled and rendered into a Reconciliation Report. The project manager works together with the translators to resolve differences until both versions of the translation share the same meaning.
In the life sciences, back translations are an essential element of quality control for life science companies and are often required by Institutional Review Boards (IRBs) and Ethics Committees (ECs) for clinical trial materials. Beyond clinical trial documentation, back translation is required for common medical documents such as surveys, questionnaires, marketing materials, informed consent forms, protocols, and more.
CSOFT Health Sciences’ team of medical professionals and subject matter experts (SMEs) can provide back translation and reconciliation services in more than 250 languages, giving life science companies the highest-quality translations for the best ROI.
Back Translation for All Your Translation Needs
Our team performs back-translation for, but not limited to, the following project types:
- Package information leaflets (PILs)
- Patient instructions
- Patient-reported outcomes
- Patient recruitment materials
- Clinical trial protocols
- Patient questionnaires
Our Team
We work closely with an independent team of medical professionals to perform back translations:
In-Country Cultural Experts
Native Language Speakers in Target Countries
Qualified Linguists
Our Methodology
CSOFT Health Sciences guarantees medical translation methodologies that are compliant with regulatory and legal standards, as required by our pharmaceuticals, medical device, and other medical product clients.
We perform a three-step quality control approach through back translation, discrepancies comparison, and reconciliation to provide the most accurate back translation. We also ensure certificates of accuracy are delivered with the translated documentation.
Linguistic Validation Services
Effective linguistic validation is essential for ensuring accurate translation of clinical outcome assessments in multilingual clinical trials. This complex process requires managing medical terminology, forward translation, linguistic harmonization, back translation, and reconciliation by linguists and clinicians. These steps standardize patient-reported data across trial sites, providing valid measurements for faster regulatory approval.
Learn more about our Linguistic Validation Services.
Quality Assurance
CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have at least seven years of experience and work with in-country reviewers and project style guides to meet industry standards. CSOFT offers an online translation management ecosystem for one central location to leverage real-time translation memory and terminology management through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.
Learn more about our quality assurance process.
Data Security
With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage the best practices of ISO 27001. They are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.