The highly regulated medical industry is rife with challenges for pharmaceutical companies, clinical trial providers, and research and development scientists with the goal of bringing new ideas to market. In addition to following strict regulations, you will also have to deal with paperwork to ensure your chance to move on to the next stage in the process. There are many cases where you have to translate documents into another language – and this is also a mistake many project managers are prone to make.
A poor quality medical translation has terrible consequences. A potentially life-saving drug could also be delayed from reaching the market. The company can spend millions of dollars just to get the regulation passed without losing the opportunity to invest in technology. For important things like creating a new drug or device, it's important to use specialized translation software to avoid errors as much as possible.
Regulations on Translations and Medical Documents
Limitations on drug approvals, clinical trials, and studies can vary widely. Usually, the higher the risk, the more stringent the criteria. The legal hurdles become more severe as the company tries to enter other markets. Each country will have its own restrictions when it comes to testing new products to put on the market. Thereby, there are many relevant content factors to consider.
Applications for approval, as well as clinical trial documents, studies, results, and intended uses, all need to be translated into the local language to be considered.
Notification document passed
All clinical trial participants need to fully understand their rights and potential risks of participating. Failure to translate these details can lead to serious liability issues.
Request a label
Packaging and labels with appropriate warnings, side effects and contraindications should be translated into the local language, as well as the minority language.
Specialists will need detailed instructions on when and how to use medicines and medical devices. All of this needs to be translated close to the original to ensure all necessary information.
Print marketing tools
Most regulators will require all public documents to be submitted for review and approval before being released. This has to be done months in advance of launch.
While these are some of the more translated focuses when using medical products or devices to enter new markets, this is by no means an exhaustive list. In most cases, there are almost thousands of pages of content that need to be translated, which is why it is so important to find a translation service that can handle the challenges involved.
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The 5 Most Important Elements of Medical Translation Software
Medical translation is extremely complex and not as simple as it can be done at home. To solve the problem, you can take the initiative in control simply by finding an expert partner agency that owns the information zoning management platform. The best medical software will feature:
The term base is obviously an important part of any medical translation software – as is translation memory and other languages. The term base is a collection of commonly used terms and phrases in the language in question, which will support organizational purposes as well as grow as the terminology changes. The term management tool ensures consistency across multiple languages.
In the case of legal restrictions, the translation must accurately reflect the original text. Translators handling requests from medical professionals need a medical background to understand and customize content for different markets.
When entering a new medical market, information will be provided in a short time. Overdue, the project can last several years, so the completion time must be fast.
While many translation software can offer major languages, not all will give you the access to the regional and ethnic languages you need. Good software will provide an endless list of translation options to ensure you don't have to search for an alternative translator for less common languages – and start from scratch with different terminology and tools.
Obviously, patients need to keep confidentiality, as it is tightly regulated and can be subject to fines. At the same time, corporate espionage is a real threat in the medical and pharmaceutical research industries. The software must have the highest security standards to ensure the protection of your intellectual property rights.
Choosing the best medical translation software can help ease your transition to different markets, so you can give them the solutions they need faster. With the right partner, you can tackle complex legal hurdles in many different countries at once. Delays come at a cost, translation services are not a novelty. They are absolutely necessary.
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Company idichthuat offers you the best medical translation software to bring your innovation to new markets and improve lives worldwide. Contact idichthuat for specific advice.