Role of Translation in Clinical Research
A large and ever-rising proportion of clinical research is done in multi-country trials, and many drugs that are marketed in the US are developed or manufactured abroad. Even US-based drug developers recruit the vast majority of the subjects for clinical studies outside the US. According to FDA’s OIG report, more than 3/4 of all the subjects in clinical trials under FDA’s INDs were from outside the US. For biologics, the share of non-US subjects in FDA-regulated trials constituted 87%.
Translation is required at many stages in the course of bringing a drug to market, including clinical research, regulatory submissions, manufacturing, marketing and packaging. While the direct cost of translation is very small, translation can have a surprisingly large effect—for better and for worse—on several crucial factors. These factors include the total cost of the trials, the time to market, the possibility of lawsuits or rejection by regulators and even the safety and efficacy of the marketed product.
For instance, regulators sometimes reject applications or delay their approval if the required translations are inadequate. As a result, cost can increase dramatically, and market entry can be delayed by months if not years, with loss of competitiveness.
Moreover, inadequate translation can mask crucial links between the data from research sites which operate in different languages. Such “lost” links might have alerted the sponsor that the compound tested is a “blockbuster” or, alternatively, a poison. Thus, inadequate translation can have enormously high indirect costs. The loss of data quality cannot be compensated by improving another part of the development process.
Medical Translation Services for Drug Companies
Medical translation requires precision and up-to-date technical knowledge—by every member of your translation team. It also requires multiple levels of quality control and a full understanding of stringent regulatory laws, especially the regulations on new drug development and marketing in the United States, the European Union, and Japan. This is precisely what we excel at!
We are a leading provider of specialized medical translation services in the United States. Pharmaceutical companies, clinical research organizations (CROs) and biotechnology firms have come to rely on us for translation of their most critical documents. Our unique Methodology of Quality Management for Medical Translation that clients depend on delivers consistently clear, accurate translation of high-value information.
The Types of Medical Documentation We Translate for Drug Companies
The typical documents we translate for our Pharmaceutical Industry clients include:
- Adverse Event Source Documents
- Case Report Forms (CRFs)
- Data Sheets
- Development Safety Update Reports (DSURs)
- Drug Registration Documentation
- Endpoint Adjudication Documents
- Informed Consent Forms
- Insert Leaflets
- Instructions for Use (IFUs)
- Marketing Collateral
- Master Batch Records
- Package Inserts and Labels
- Patient Diaries
- Patient Recruitment Materials
- Patient Reported Outcome Measures (PROMs)
- Patient Source Documents, Admission and Discharge, Labs
- Pharmacological Studies
- Product Labels
- QoL Scales
- Regulatory Documents
- Scientific Papers
- Study Protocols
- Suspected Unexpected Serious Adverse Reactions (SUSARs)
- Toxicology Reports
We translate medical documents such as these between English and over 215 global languages, including all the major languages of Western and Eastern Europe, Asia, America, Africa and the Middle East, including Chinese, Dutch, French, German, Hebrew, Italian, Japanese, Korean, Portuguese, Russian and Spanish.
Translated and Certified by Medical Professionals
We have an experienced team of translators, interpreters and editors with impeccable linguistic skills, technical writing expertise, and—most important—professional degrees such as MDs and PhDs in all major areas of life sciences and medicine.
Our meticulous quality control system is the most thorough in the industry, with a system of checks and balances in place throughout the entire process—from the selection of project managers to the final proof-reading of the document. Click here for details about Language Scientific’s Quality Control Methodology for Medical Translation.