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Translation for life sciences

The highly regulated and unique requirements of the Life Sciences sector mean finding a high-quality translation partner who understands your needs is essential.

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With specialised workflows specifically designed for the life sciences sector, ALM’s life science translation service is trusted by some of the world’s largest organisations as well as renowned smaller companies in this sector.

ALM is both ISO 17100 and ISAE 3000 part 2 accredited, which is your guarantee of accuracy, robust processes, security and quality to give you peace of mind that you are in the safest of hands.

What services do we do for the Life Sciences sector?

Translations for drugs and medical devices

All ALM’s life science translators are strictly vetted and regularly trained to ensure high translation standards are met.to avoid Inconsistencies in drug and device information that could potentially have severe consequences.

Information for medical practitioners

Due to the different fields worked in by medical practitioners, using a translator with the right experience is paramount to making sure information is correctly presented in the target language.

Submission of centralised marketing authorisation applications for the European Medicines Agency (EMA)

Support in planning the linguistic stages of your MAA right through to the final submissions of translations compliant with QRD requirements and in line with EMA requirements.

Regulatory correspondence

In order to provide the highest quality regulatory correspondence translations, ALM ensures translators have up-to-date regulatory knowledge relevant to their target market.

Manufacturing records for audits

If you produce goods in the life sciences sector, manufacturing records are a requirement. In-market experts ensure records are translated and presented correctly within your operational markets.

Clinical Trials

A strictly regulated aspect of the life sciences sector, ALM understands that pharmaceutical companies face several challenges when conducting clinical trials. ALM Translations uses native-speaking professionals with experience in providing content within this sector.

Communication with Ethics Committees

As your clinical trial progresses, ALM supports your trial by providing ongoing and consistent translation to facilitate your obligations in providing the required submissions to the relevant ethics committees.

Documents about trial investigators and sub-investigators (CVs etc.)

ALM has implemented custom workflows to ensure data from clinical trials remains confidential and that the end translation is compliant for documents such as investigator brochures and informed consent forms.

Participant information

Your translated information must be clearly and precisely provided for participants in your clinical study or trial. Professional translation services will give you the assurance that the information will be clear and accurate.

Medical notes for trial participants as part of Adverse Event recording

Our translators are experienced in working with Adverse Event recording documents, necessary in order to promote and improve patient safety in clinical studies.

In-market, quality-driven linguistic team

We take several steps to guarantee the highest level of quality in Life Sciences translation, starting with the careful choice of linguists selected for their sector experience, qualifications and work history.

All linguists are provided with continuous training from ALM through sharing best practices, research techniques and standard documentation. All appropriate reference material is shared at a group level, and following an initial translation, all translated documents and materials are subject to a detailed multi-stage review.

As a final step, texts are back translated and reconciled to verify the accuracy of documents. Back translation is a safety feature involving a second translator who translates the completed text back to the original source language to highlight any possible discrepancies. This process allows us to guarantee our work for sensitive applications such as drug leaflets.

The credentials of our linguists and their understanding of the regulatory requirements in the UK and internationally is underpinned by a rigorous quality control system. Our ISO17100 certified quality system governs everything from the selection of project managers to the final proofreading of the translated document.

To maintain the highest translation standards in this sector, we focus on 3 core quality pillars.

Accuracy

Above all, creating highly accurate translations is a priority for the team at ALM. By using in-market specialists we ensure text is localised to remove the possibility of important messages being lost in translation.

Consistency

Keeping terminology consistent across translated documents so that instructions are clear, e.g., not using two different terms for the same item “needle” and “syringe”. We also adhere to international standard QRD templates for drug information.

Audience

Using the appropriate register is an important factor. Some documents are aimed at medical personnel and others address the general public – the translation must take the readership into consideration and use appropriate style and wording.

Documents to be read by medical professionals must use specific terminology to ensure information is conveyed quickly and accurately, with no room for confusion.

Documents to be read by the general public must be as clear and simple as possible and not use complex terminology – a low reading ability must be assumed to ensure they are accessible to all.

What are the benefits of partnering with a specialist Life Sciences translation agency?

World Dots

A partner that understands the unique requirements of the sector

  • Bespoke workflows including triple checked translations
  • Triple checked translations, back translation and source reconciliation
  • Translators qualified to translate regulatory documentation for their respective markets

Dedicated Project Managers experienced in the Life Sciences industry

  • Trained in a variety of work types such as EMA and clinical trials
  • Industry-leading translation memory software used as standard
  • Integration with client-side systems for increased efficiency and accuracy

ISO 17100 and ISAE 3000-part II accredited

  • Subject matter expert native speaker translators and reviewers
  • Confidential data handling
  • Approved partner for some of the largest Life Sciences organisations in the world

For further information about how we can support you with specialised life science translation please get in touch today.

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