Due to the complex nature of the terminology and the sensitive use of the target files, the translation of medical documents and materials requires a different workflow than many other written translation projects.
Traditionally, translation is more of an art than a science. A ten-word sentence may have fifteen “correct” translations, with each well-suited for one target audience or another. Medical translations, however, are on the spectrum of translations that are more science than art.
By only working with subject-matter experienced translators with a minimum of five years of medical translation experience, we are able to achieve high-level, nuanced translations of often-complicated subjects.
In addition, we prefer our translation experts to have familiarity with the medical specialty or subspecialty of concern, rather than a more general field. For example, a translation specialist with experience in radiology or biology may not perform as well as one experienced in the more specialized field of musculoskeletal radiology.
Hospital Systems, Regional Dental & Medical Practices, Biotechnology Companies, Global Pharmaceutical Companies, Pharmaceutical Manufacturers, Medical Devices Companies, Clinical Research Organizations (CRO)
Other critical factors include the use of bi-lingual medical dictionaries, access to client glossaries, and the use of translation memories. With the many thousands of medical terms in use today, it is nearly impossible for a medical translator to accurately complete the work without the help of specialized resources.
Additionally, proofreaders and editors play another critical role in ensuring quality. Their understanding of the subject matter and personal skill sets are just as important as the primary translators. That work requires a very careful study of both the original and target text while keeping in mind the project specifications outlined by the client.
We are well-positioned for success because of our thorough linguistic vetting and onboarding process, and the vast understanding of our team’s abilities. Being able to match skill sets with project specifications and client deliverables is time-consuming and sometimes difficult, but we understand the importance and have processes in place that make it seamless.
TYPES OF MEDICAL DOCUMENTS WE TRANSLATE
Safety Data Sheets, Reports, Informed Consent Forms, Manufacturing Process Descriptions, Business Contracts, Medical Charts, Adverse Events, Package Inserts and Labels, Case Report Forms (CRF), Patient Information, Clinical Protocols, Patient Reported Outcomes (PRO), Clinical Trials, Patient Recruitment Materials, Employment, Contracts, Business Plans, Pharmacological Studies, CRA Training Materials & Videos, Product Labels, Production Manuals, Dossiers, Organizational Protocols, Drug Registration Documentation, Questionnaires, Quality of Life (QoL) measures, Instructions for Use (IFU), Rater Scales, , Regulatory Audits, Regulatory Documents, SAE and SOP Procedures, Batch Records and Deviation Reports, Journal Articles, Marketing Materials, Software and Hardware, Multimedia audio and visual, Toxicology Reports, Confidentiality Agreements, Organizational Websites, Internal Portal Systems, Medical Supply descriptions, Medical insurance documents, Hospital discharge papers, Scientific publications, Hospital records, Medical records, Regulations & Legislation, Clinical Study reports, Clinical Protocols, Scientific research, Test and analysis results
LINGUISTIC VETTING CONSIDERATIONS
Years of Experience
Phone, Video or live in-person interview
Monitoring of performance
Past work experience
Subject matter experience
Understanding how the native and non-native languages were learned
TB Translation’s Quality Assurance (QA) process for medical translations considers the guidelines recommended by ISO 17100 and ASTM 2575.
Our multi-level quality control procedure includes detailed workflows for each step of the process, clear and transparent client deliverables and project specifications, and a system of checks and balances to ensure your needs are met. We are confident that our clients can rely on us.
The circle of trust between project managers, account managers, translators, and quality specialists sets us apart from other Language Service Providers.
A summary of our project management and production process is below:
Identifying requirements and following the procedures and specifications throughout production
Matching the translator’s language competencies with the requirements of the project
Assigning a competent Proofreader
Issuing instructions for the assignment and managing the translation project to all parties involved
Monitoring to ensure compliance with agreed upon schedule and deadlines
Communicating any changes of the project specifications
Maintaining conformity to the client-LSP agreement
Ensuring questions are answered
Managing and handling feedback
Verifying that the specification have been complied
Delivery of the final work product
Implementing corrections and/or corrective action
Within each of these steps, we are able to add customized workflow options at the linguistic matching or quality assurance level. For example, some clients require “back-testing” to be performed. This is the translation of the translated file back to the source language test.
Moreover, our understanding of the stringent regulatory laws—especially in the US, the European Union, and Japan—gives us the background to be domain experts, guiding our client’s projects in the right direction.
This regulatory framework reflects the importance and sensitivity of these medical materials, which is why translators and editors in this specialty go through a more advanced analysis of their background and skillsets and additional testing during the onboarding process.