Trying to take a shortcut through the FDA approval process with a “good enough” standard translation of your clinical trial can disrupt your go-to-market strategy. In fact, the FDA is known to reject submission documents that lack a translation certificate of accuracy. While this scenario presents substantial business challenges, the implications are even more severe in terms of public health. When human lives depend on your clinical trial results, every day of delay means more patients don’t get access to essential healthcare.

That’s why life science translation services must follow rigorous standards. Linguistic validation, certifications, and expert knowledge are crucial to launching and completing your clinical trials, protecting public health, and maintaining scientific integrity. Certified translations are fundamental to meeting these standards, as they provide the accuracy and technical expertise required for official use.

What Exactly is a Certified Translation?

A certified translation is a document that simultaneously meets two essential conditions:

1. A qualified translator translates all content from the original document precisely.
2. It must include a certificate confirming its fidelity to the original.

In the life science industry, the documents most likely to require a certified translation include those related to:

• Clinical trials: Medical documents, informed consent forms, clinical trial agreements, and clinical research protocols (to ensure participant understanding and compliance with international regulations)
• Medical devices: Instructions for use, safety data sheets, and regulatory submissions (to meet the standards of different regulatory bodies)
• Pharmaceuticals: Drug packaging, patient information leaflets, and marketing materials (to accurately convey dosage instructions, side effects, and marketing claims)
• Research and publications: Research papers and scientific publications (to ensure that findings are accurately represented and can be reviewed by international peers)

The Difference Between Translator Certifications, Quality Certifications, and Certified Translations

Each serves a distinct function:

• One validates the translator’s expertise.
• One ensures the quality of the translation process.
• One attests explicitly to the accuracy of a single translated document.

Let’s take a closer look.

Translator certifications validate an individual translator’s proficiency. They often come from professional organizations, like the American Translators Association (ATA), confirming that the translator has met specific professional competence standards.

Quality certifications ensure that the translation service provider follows best practices and maintains a high level of quality throughout the translation process, which is crucial for life science translation services.

• ISO 17100 specifies requirements that can impact the quality and delivery of translation services.
• ISO 9001 sets out the criteria for a quality management system, including a strong customer focus, top management involvement, a process approach, and continual improvement.
• ISO 13485 specifies requirements for a quality management system in which an organization must demonstrate its ability to provide medical devices and related services that meet customer and regulatory requirements.

Certified translations confirm the accuracy and completeness of a single translation. If you need to translate your life sciences or clinical trial documents into five languages, you will require five certificates of accuracy or the equivalent documentation for each target market. The certificate, signed by the translator or an authorized third party, asserts that the translation is a true and accurate representation of the original document.

Why Certified Translations Matter for Clinical Research Organizations (CROs)

Certified life science translations guarantee accuracy and compliance.

In the US, the FDA mandates that the source of any translation accompany the foreign language equivalents. This translation must include the translator’s name, address, and a brief statement of their qualifications. Additionally, translations of literature or other materials must include copies of the original publication.

The rules admit no exceptions. At Hansem Global, we recently assisted a pharmaceutical company that faced significant delays and costs due to uncertified translations. The company had to hire us to urgently review 100 pages of English-to-Chinese documents and provide a certificate of accuracy. This oversight resulted in hundreds of thousands of dollars in expenses and potential market losses due to delays.

Similar stringent regulations exist worldwide, reflecting the complexity of approving medical devices and pharmaceuticals. Clinical research organizations (CROs) and other entities involved in clinical trials must ensure their translations are accurate to comply with these regulations. Many countries mandate that only certified professionals translate documents submitted for approval. Some local authorities may also require specific formats, notarized affidavits, or additional certifications. Neglecting these steps can lead to regulatory setbacks, financial loss, and damage to your reputation in the industry.

How to Get a Certified Translation

Knowing each step—from the initial assessment and translator selection to the translation, review, quality control, and certification—helps you anticipate timelines, manage expectations, and navigate potential challenges effectively.

Here’s a detailed look at the process:

• Initial assessment: The project manager and team will evaluate the documents to understand their complexity and specific requirements. 
• Translator selection: The project manager will then assign qualified, certified translators based on their expertise in life sciences translation services.
• Translation: The expert will translate the document word-for-word, ensuring that all original content is accurately translated into the target language.
• Review and quality control: The translated document will undergo multiple reviews and quality control rounds. This process involves a second translator or a subject-matter expert.
• Certification: Once the translation is verified, the translator will provide a signed certificate attesting to its accuracy and completeness.
• Delivery and final review: You receive the certified translation and the certificate of accuracy.

Now that you understand the necessary steps, let’s explore how to find the right professionals to partner with for your life science translation needs.

Choosing an experienced Language Service Provider (LSP)

The LSP should have in-depth knowledge of the life sciences industry, including pharmaceuticals, biotechnology, medical devices, and clinical research organizations (CROs). This way, you can guarantee that the experts handling your clinical trial documents understand the complex terminology and specific regulatory requirements.

For the best outcomes, find a team with a proven history of translating clinical trial protocols, regulatory submissions, and patient information leaflets.

Case studies or client testimonials can provide insights into their performance.

Here are a few pro tips:

• The LSP must offer linguistic validation services, particularly for patient-reported outcomes (PROs) and clinical outcome assessments (COAs).
• Work with an LSP with experience in the regulatory requirements of different countries, including the FDA in the US, EMA in the EU, and other regional authorities.
• Ask about their processes and tools. When used correctly, advanced translation management systems can enhance the quality and efficiency of the process.
• Ask for comprehensive quality assurance that includes multiple reviews and editing by subject matter experts.

Clarifying the Scope and Purpose of the Translation

If the target language has regional variations (e.g., Brazilian Portuguese vs. European Portuguese), specify the exact language so the translation is culturally appropriate.

Another crucial detail is the document’s purpose, which helps the translator adjust the language appropriately. For example, a patient information leaflet aimed at trial participants will use more straightforward, accessible language, while a regulatory submission requires precise legal and scientific terminology to meet the standards.

Also, you should:

• Supply the LSP with all necessary reference materials, including glossaries, previous translations, specific terminology databases, and style guides.
• Give detailed contextual information about the document. This includes the background of the clinical trial, the regulatory framework it must comply with, and any specific instructions or nuances that need to be considered.
• Establish clear lines of communication with the LSP for any clarifications during translation. Regular updates and feedback loops keep the translation on track and ensure compliance and accuracy.

Other Key Considerations: AI and Costs

Two more things to consider include the use of AI and the cost factors to be aware of.

• We don’t recommend using AI. Even the latest AI technology can only partially comprehend the intricacies and bureaucratic nuances involved. The human touch at every stage ensures that the translation adheres to the necessary regulatory and contextual requirements.
• Due to the extensive review and certification processes, certified translations are more expensive and take longer to complete. Additional fees may apply for expedited services.

Conclusion and Next Steps

Yes, high-quality certified translations are a regulatory necessity. But they’re also a strategic advantage that supports the integrity and success of your clinical trials and medical products.

With certified life sciences translations, you can be confident that your clinical trial documentation meets all industry standards, helping you achieve your goals and respect your deadlines and go-to-market timeline.

It’s essential to engage with the best possible experts who have in-depth knowledge of your field and the experience to meet the specific requirements of authorities in your target market.

At Hansem Global, we work with certified and professional medical translators ready to assist you with life sciences translations. Our expert team is here to ensure your translations meet the highest standards of accuracy and compliance regardless of your target market.

Connect with us to learn more about our certified life sciences translation services and how we can help you meet compliance with local authorities worldwide.