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Pharmaceutical Industry
Role of Translation in Clinical Research
A large and ever-rising proportion of clinical research is done in multi-country trials, and most drugs that are marketed in the US are developed or manufactured abroad. For example, the share of clinical programs conducted exclusively in the US has declined over the past decade, from a high of 80% to 24% currently, according to an FDA study of approved oncology drugs. On the other hand, approved drugs for which data were derived from foreign clinical trial sites rose from 50% in 1998-1999 to 75% in 2000-2002.
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:
Case Report Forms (CRF)
Clinical Trials
Data Sheets
Drug Registration Documentation
Manuals
Package Inserts and Labels
Patient Questionnaires
Product Labels
Scientific Papers |
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Clinical Protocols
Consent Forms
Dossiers
Insert Leaflets
Manufacturing Process Description
Patient Information
Pharmacological Studies
Regulatory Documents
Toxicology Reports |
We translate medical documents such as these between English and over 100 global languages, including all the major languages of Western and Eastern Europe, Asia, South America, and the Middle East, including Chinese, Dutch, French, German, Hebrew, Italian, Japanese, Korean, Portuguese, Russian, and Spanish.
Translated and Certified by Medical Professionals
RIC has 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. Details about RIC International's Quality Control Methodology for Medical Translation are described in this section.
How to Obtain More Information To learn more about our medical translation services, or to request a proposal, please call us at 800.240.0246.
If you prefer, you can send us an e-mail at info@ricintl.com. But we would rather talk to you in person! |
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