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Pharmaceutical and Medical Device Translations

Pharmaceutical and Medical Device Translations

By | Pharmaceutical Translation | One Comment

As with just about every industry today, products are being marketed to the international community. In most cases, whether it’s a product handbook or a warranty document, accuracy is important in professional medical translation and that means 100 percent accuracy. If there is even one mistake in either a pharmaceutical translation or a medical device translation the recipient could get seriously injured.

The sorts of details that need to be translated include measurement units that must be recorded accurately otherwise the user may not take enough or take too much of the drug resulting in some dangerous side-effects. Other information includes that found on packaging and information leaflets. If a medicine is in pill or tablet form and has a dosage clearly written on the label in the languages of the likely recipient it’s unlikely that the product will be misused.

However, if a medicine is given as a powder or syrup the amount to be taken has to be clearly illustrated. If the pharmaceutical is being prescribed to an American, but in metric form, it’s important that the product advertises the amount to be taken in the right measuring language. Americans aren’t necessarily proficient at understanding metric quantities.

The packaging on the drug NyQuil is a good example as it includes both the US customarily used units as well as metric units, so 30 mL equates to 2 TBSP. these need to be translated into key languages used in the targeted countries.

Drugs versus medical devices

The initial stage of a drug trial focuses on a small unit of healthy patients first however with medical devices it’s not acceptable to install them on people who have no need for them. Also, devices typically require a smaller study group in order to demonstrate the safety and effectiveness of them than pharmaceuticals require. So, the 4 phase study for pharmaceuticals comprises a healthy population group, a small affected population, a larger affected population and the post-approval study is substituted for a 3 stage process, which comprises a small pilot group, a bigger patient group and a post-approval group.

What’s important about a translator?

100 percent accuracy is the goal of any professional medical translation, so the translator should be very familiar with the correct term in order to ensure readability, accuracy and the credibility of the author of the text. The deeper the pharmaceutical and device translator’s knowledge of the vital subject matter, including documents that have come from the country’s regulatory body the better the translation of the required documents.

Veterinary Translation

Veterinary Translations are Necessary in Today’s World

By | Veterinary Document Translation | No Comments

Translation is a field that involves all sorts of disciplines, from the translation of legal documents, scientific documents to business documents, medical device documents and even veterinary translation services. Animal lovers and owners and even farmers these days don’t necessarily live in their country of origin. Even though they consider themselves fluent when they relocate to a new country, there are some disciplines like veterinary work that uses a specific language which they may never been exposed to except in their own language.

As with medical documents, translation of veterinary documents is very important. Veterinary translation services have a role to play that is key to any country that has a variety of different language speakers. When it comes to the customer using veterinary services it’s important that he or she can understand any treatment provided for their animals and its consequences.

Most information is provided in the national language of a country as a first priority, but with so many people now living outside their country of origin who might not have the language skills to understand technical veterinary documents, it’s imperative that suppliers of drugs and devices to veterinary clinics ensure that product information is translated into the key languages of the speakers who are high users of veterinary services.

Animal lovers may even like to know more details about treatment options and their side-effects so if they don’t speak the language well of their host country they will want to see the material translated into their language. The same can be said of farmers who may have invested in purchasing a farm out of their own country but who can’t understand the information provided with veterinary products. They may have the farming skills, but not the veterinary knowledge.

Other reasons for a veterinary translation

There are many scientific and clinical trials carried out on veterinary products that to be useful to the world community need to be translated into the world’s key languages. Additionally, textbooks for veterinary studies need to be made available in the languages used for study purposes around the world.

Pharmaceutical Manufacturing

Translating in a Pharmaceutical Manufacturing Environment

By | Pharmaceutical Translation | No Comments

Language is so much based on context that when a lot of time has been spent writing a text it still may be open to the way the reader interprets it. This is even true with translations. It is only those translations that have been completed by a highly trained and experienced translator will mean that interpretation of the translated text resembles that of the source text.

There are some pharmaceutical interpretations that may have a narrow interpretation and those that have a broader scope for translation. The problem arises is how the reader should safely interpret the information provided in the pharmaceutical document. If a translator from pharmaceutical translation services, is presented with a pharmaceutical document and doesn’t fully understand the document his or herself because of ambiguities present the only recourse is to go back to the person who wrote the document in the 1st place. Translators for medical translation services who are not given this option should inform their clients of any contradictions or ambiguities found in the source document. It doesn’t take much to work out who is likely to be held responsible for any contradictions or ambiguities that are found in the translation.

Once the translator has gained a reasonable understanding of the source document for the medical and pharmaceutical translation, the translation is almost ready to commence. There are a few other things that need to be considered apart from the actual meaning of the text. These are the voice, mood and person used with the verb. Whether an action needs to be performed or there is a choice. Instructions need to be expressed and translated in the same way in the original as in the translated documents. In the standard operating procedures used in the pharmaceutical industry it’s important that consistency in meaning is maintained to ensure the product is used appropriately.

Another common issue in English is the use of words used in instructions like check and other verbs suggesting an action. For example, you should check for leaks. This appears to mean that the product instructions are telling you to make sure there are no leaks. It could read that you are told to make sure there are leaks. It’s important for the translator of medical and pharmaceutical translations that the precise meaning of the instruction is clear so that it can be translated into the targeted language without compromising the meaning.

Outsourcing Clinical Trials

Challenges in Medical Translation for Outsourcing Clinical Trials

By | Medical Document Translation | No Comments

Before a drug is released for public use it has to undergo thorough trials some of which take more than 10 years to complete and can cost at least a million dollars. Not all clinical trials necessarily take place where the drug is produced and these days many take place in Asian countries where the monitoring process and reporting will take place in a language other than English. Translating Clinical Trial papers can only be successful if the medical translators understand the likely pitfalls if the medical translation is not taken seriously.
Breakdown of Clinical Trials

Clinical trials follow 5 distinct phases which are:

● Commencement of drug testing on non-humans to test toxicity and pharmacokinetic information.

● Testing the drug on healthy volunteers in order to calculate dosage requirements. This could also be cancer victims if the drug is an anti-cancer drug.

● Testing the drug on patients who have certain medical conditions to test for potential side-effects.

● Testing the drug on patients with certain medical conditions and assess dosage level.

Post-marketing monitoring in force to double check the effect of specified dosages on real patients.
Medical device manufacturers and pharmaceutical companies have been outsourcing clinical trials to Contract Research Organizations (CROs) for a number of years. A spokesperson for OutsourcingPharma.com reported that in 2014 the world CRO market had a value in excess of $27 billion and this is expected to increase at 6 percent per year over the coming years. North America has the lion’s the share of the CRO market with Europe following, while the Asia-Pacific is becoming the fastest growing area for CRO activity.

When outsourcing clinical trials, there are many medical translation challenges. This is because it is necessary to adhere to regulatory requirements, approval procedures, and medical conduct where the CROs operate. Medical translation of this nature requires far higher attention to detail than other kinds of translation, as a poor translation could put people’s lives and health at risk. To put it quite simply, when clinical trials are outsourced to countries where those involved don’t speak the language of the CRO, attention to a medical translation is far more important.

When medical translations are provided for clinical trials, the medical translators involved must consider carefully the target audience whether it’s medical personnel or a layperson. For example, medical terms such as “hypotension”, “tinnitus” and “myalgia” when defined for the layperson in mind would be “low blood pressure”, “ringing in the ears” and “muscle ache”.

Medical Device Translation

The Standards that are Set for Translating Medical Device Information

By | General | No Comments

In the European Union (EU) alone, the medical devices industry attracts yearly sales that exceed 95 billion euro. It also employs 570,000 people. The EU has 24 official languages that are spread throughout 28 states, 9 more remote regions and 21 territories and overseas countries. If a medical device is to be marketed in the EU that’s an awful lot of translation work to effectively cover every possible language. So basically a medical device is a big deal in the EU.

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Life Science Translations

All You Need to Know About Life Science Translations

By | Translation Tips | No Comments

Science translations are more important today than they have ever been. More and more research is being carried out in universities and scientific research institutes in a multitude of languages. For the data collected in research projects there is a need to spread the information far and wide across the globe so that the data can further the research efforts of the global scientist. To share with a large group of scientists it’s important to get the research papers translated into as many different languages as possible so discussions can be had, additions made and conclusions can be drawn as to the value of the research.

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Clinical Trial Translation

Why Clinical Trial Translation is Necessary

By | Translation Tips | No Comments

It may not be generally known that many clinical trials of drugs are actually carried out in developing countries. That includes clinical trials which are regulated by the U.S. Food and Drug Administration.

The main reason for using these countries is because they are a lot cheaper to carry out than in a developed country like Australia, the U.K. or the U.S. The savings can amount to 90% of what they might cost at home.

Clinical trials of new drugs on humans require a lot of care to ensure that no-one is hurt, but at the same time the drug is sufficiently tested that it can be released for safe use elsewhere.

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Experienced Medical Translator

Using an Experienced Medical Translator is Best

By | General | No Comments

It might be surprising to know that in the United States more than 60 million people speak a language which is not English but is their preferred tongue. This means that people working in the medical profession invariably come across patients that are LEP (Limited English Proficiency). The physician knows that an LEP patient is at risk if there is a problem with understanding one another. Read More

Errors are Unacceptable in Medical Translation

Errors are Unacceptable in Medical Translation

By | General | No Comments

It cannot be emphasised enough just how important it is that any sort of medical information is presented accurately, concisely and completely. This order of importance takes on new meaning whenever medical text of any sort is translated from one language to another. The prospect of even a simple error is very serious. Any business or government organisation that has anything to do with generating medical information must ensure that they use a professionally qualified medical translator whenever the need for translation arises.

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