Jim Cohen
Clinical Trial Translations: The Five Keys to Success
Introduction Clinical trials are essential for determining the safety and efficacy of new drugs or medical devices. These trials also produce a significant volume of documentation that must then be translated into various languages. Given the stringent safety and regulatory requirements in this field, accurate and high-quality translations are critical. [...]
Beyond “English”: How International English Benefits Translation Clients
Introduction English is the global language of business, travel, and communication. It’s also the most commonly spoken language in the world. If you count both people whose first language is English and those who learned it as a second or third language, there are nearly 1.5 billion speakers of English [...]
Medical Device Translation: Ensuring Regulatory Compliance
Introduction The critical nature of medical device translations When it comes to translating documents for medical devices, precision is paramount. Imagine if a crucial instruction for use (IFU) or warning label were translated incorrectly, putting patients’ health and lives at risk. This example underscores the importance of accurate translation in [...]
The Importance of Translation for Good Manufacturing Practices (GMP)
How High-Quality Translations Help Ensure GMP at Pharmaceutical and Other Companies Good manufacturing practices (GMP) have been developed to ensure consistent and high-quality manufacturing processes. Safe processes are especially important in industries like the pharmaceutical sector. Failure to adhere to the required level of quality can result in harmful effects [...]
In Plain Sight: Translation and Plain Language
How plain language can ease the translation process We’ve all come across a text, online or in print, that has stumped us. It uses words we don’t understand (jargon or uncommon terms). There is a complicated syntax that can’t be untangled. The text attempts to convey complex ideas in a [...]
Multilingual SEO: The Key to Growth in the Digital Era
The importance of multilingual SEO in a globalized world Thanks to the internet, companies are no longer limited to a specific geographical location when trying to reach new customers. The web connects people around the world, giving businesses an unprecedented opportunity to engage a global audience. Multilingual SEO (search engine [...]
Helping with the development of a groundbreaking cancer treatment
Introduction Poniard Pharmaceuticals, a leading biopharmaceutical company specializing in oncology treatments, faced a significant challenge when it developed a new drug to treat kidney cancer. The innovative treatment contained precious metals and involved complex manufacturing processes. Poniard was seeking FDA approval of the drug, but because it was working with [...]
The Importance of Linguistic Validation in Evaluating Clinical Outcome Assessments
What is linguistic validation? Linguistic validation is a crucial process that ensures accurate and culturally appropriate translations of survey instruments, patient questionnaires, and other clinical trial documentation. It is a fundamental aspect of global research and communication, especially in multicultural and multilingual settings. The goal of linguistic validation is to [...]
Clinical Trial Translations: The Five Keys to Success
Introduction Clinical trials are essential for determining the safety and efficacy of new drugs or medical devices. These trials also produce a significant volume of documentation that must then be translated into various languages. Given the stringent safety and regulatory requirements in this field, accurate and high-quality translations are critical. [...]
Beyond “English”: How International English Benefits Translation Clients
Introduction English is the global language of business, travel, and communication. It’s also the most commonly spoken language in the world. If you count both people whose first language is English and those who learned it as a second or third language, there are nearly 1.5 billion speakers of English [...]
Medical Device Translation: Ensuring Regulatory Compliance
Introduction The critical nature of medical device translations When it comes to translating documents for medical devices, precision is paramount. Imagine if a crucial instruction for use (IFU) or warning label were translated incorrectly, putting patients’ health and lives at risk. This example underscores the importance of accurate translation in [...]
The Importance of Translation for Good Manufacturing Practices (GMP)
How High-Quality Translations Help Ensure GMP at Pharmaceutical and Other Companies Good manufacturing practices (GMP) have been developed to ensure consistent and high-quality manufacturing processes. Safe processes are especially important in industries like the pharmaceutical sector. Failure to adhere to the required level of quality can result in harmful effects [...]
In Plain Sight: Translation and Plain Language
How plain language can ease the translation process We’ve all come across a text, online or in print, that has stumped us. It uses words we don’t understand (jargon or uncommon terms). There is a complicated syntax that can’t be untangled. The text attempts to convey complex ideas in a [...]
Multilingual SEO: The Key to Growth in the Digital Era
The importance of multilingual SEO in a globalized world Thanks to the internet, companies are no longer limited to a specific geographical location when trying to reach new customers. The web connects people around the world, giving businesses an unprecedented opportunity to engage a global audience. Multilingual SEO (search engine [...]
Helping with the development of a groundbreaking cancer treatment
Introduction Poniard Pharmaceuticals, a leading biopharmaceutical company specializing in oncology treatments, faced a significant challenge when it developed a new drug to treat kidney cancer. The innovative treatment contained precious metals and involved complex manufacturing processes. Poniard was seeking FDA approval of the drug, but because it was working with [...]
The Importance of Linguistic Validation in Evaluating Clinical Outcome Assessments
What is linguistic validation? Linguistic validation is a crucial process that ensures accurate and culturally appropriate translations of survey instruments, patient questionnaires, and other clinical trial documentation. It is a fundamental aspect of global research and communication, especially in multicultural and multilingual settings. The goal of linguistic validation is to [...]