The medical industry is heavily regulated and rife with challenges for pharmaceutical companies, clinical trial providers, and research and development scientists who want to bring new ideas to the market.
Aside from meeting stringent regulatory guidelines, you’ll have to deal with extensive paperwork and documentation to secure the approval you need to move to the next stage in the process. In many cases, that documentation will require translation into a foreign language—and this is where many project leaders make mistakes.The consequences of a bad translation in the medical industry are dire.
A life-saving drug may be delayed from market launch. Companies may spend millions in securing regulatory approval only to lose their investment on a technicality. When doing something as crucial as creating a new medication or device, it’s vital to use the best medical translation software to avoid errors.
Regulations Surrounding Medical Translation and Documentation
The limits surrounding approvals on medication, clinical trials, and other research can vary widely. Typically, the higher the risk to the public, the more stringent the criteria. Regulatory hurdles increase as companies attempt to enter different markets. Every single country will have its own restrictions in place with relation to testing new products and bringing them to market.In this, there are several different components of related content to consider:
Government Material
Applications for approval, as well as documents on clinical trials, research, results, and intended uses, will all need translation into the local language for officials to review.
Informed Consent Documents
All clinical trial participants need to thoroughly understand their rights as well as the potential risks of participation. Failure to accurately translate these details can create significant liability issues.
Label Requirements
Packaging and labels must come with appropriate warnings of side effects and contraindications, and they need translation based on the local language, as well as minority languages.
Additionally, to ensure accessibility and ease of understanding, these warnings can be conveniently accessed through a link to a QR code printed on the packaging.
Professional Instructions
Professionals will need detailed instructions on when and how to use medications and medical devices. All this must be accurate to the original translation to ensure the inclusion of all essential information.
Marketing Collateral
Most governing bodies will require that all public-facing material be submitted for review and approval before it can ever go in front of the public. This must occur months in advance of launch.While these are some of the more important focuses for translation efforts when reaching into new markets with a medical product or device, this is by no means a comprehensive list. There are virtually thousands of pages of content to translate in most cases, which is why it’s vital to seek out a translation service that can handle the unique challenges involved.
The 5 Components of the Best Medical Translation Software
Medical translation is incredibly complex, and it’s not something that is typically handled in-house—especially when time is of the essence. Ideally, this is an issue you can manage proactively by seeking out an expert partner agency with an existing translation management system. The best medical translation software will offer:
- Consistency: A term base is a vital part of any medical translation software—as are translation memories and other linguistic assets. The term base or glossary will hold commonly used phrases in the language in question that will support your organization’s purpose, and it will also be able to grow with it as those terms change. Terminology management tools ensure consistency across many different locales and languages.
- Accuracy: Translations must reflect the original document exactly when it comes to regulatory restrictions. Translators handling the requests from medical professionals need a background in medicine to understand and adjust the content for different markets.
- Speed: Volumes of information with very short deadlines will be required when reaching out to new medical markets. Missed deadlines can spell years in delay, so turnaround time must be rapid.
- Diversity: While many translation software solutions can offer major languages, not all of them will provide you with access to minority and regional dialects that you will need to cover your bases. Good software will offer an endless list of translation options to ensure you don’t have to seek out an alternative translator for less-common languages—and to start from scratch with your terminology and other tools.
- Privacy: The need for patient confidentiality is evident as it is heavily regulated and can result in fines and penalties. At the same time, in the medical research and pharmaceutical industries, corporate espionage is a genuine threat. The software must have the highest confidentiality standards to ensure protection for your intellectual property.
Choosing the best medical translation software can help ease your transition into different markets so you can reach consumers with the solutions they need—faster. With the right partner, you can clear the complex regulatory hurdles of many different countries at the same time. In an industry where delays can cost lives, translation services aren’t just a novelty. They’re an absolute necessity.
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