As clinical trials have emerged in the global marketplace, Pharmaceutical Organizations and Contract Research Organizations (CROs) need to be more cognizant of the challenges that can come with translating international trials.

The need for accurate and understandable translation of patient and study documents is an invaluable component of a successful clinical trial. Subject matter experts are needed to accurately translate all of a study’s materials, including investigator brochures, clinical trial protocols, Clinical Trial Agreements (CTAs), Informed Consent Forms (ICFs) and Patient Reported Outcomes (PROs).

An incorrect translation could result in delays, rejections, punitive action from regulatory bodies, or, in extreme cases, patient fatalities. Ultimately, CROs should take into consideration quality, cost and timelines when looking to translate clinical trials in order to weigh their options.

Centralizing the process by working with one Language Service Provider (LSP) can help achieve quality translations while completing the translation process on time, under budget and with reduced administration activities for research teams.

Quality: Navigating Strict Regulations

Using an LSP with subject matter expert linguists and the ability to coordinate the In-Country Review process is a huge step in developing accurate translation of clinical trial materials. When working in a highly regulated industry like life sciences, it’s imperative that native speakers are used to translate patient and study materials.

Clinical trials are regulated by a number of different agencies, including the FDA, EMA and the World Health Organization, depending on the trial’s location. Due to rigorous quality standards, translators must be familiar with medical terminology and able to account for cultural nuances in clinical trial documents.

On top of experienced translators, an LSP should also be certified in industry-recognized standards that ensure quality and accuracy. A language provider that is ISO 13485 certified has showcased its commitment to quality for medical device translations, and an LSP with ISO 9001 certification has an audited quality management system in place. In addition, LSPs with ISO 27001 should also be sought after, as this standard specifies requirements for information security management systems.

Reducing Unnecessary Costs

As the cost of clinical trials continues to increase, Pharmaceutical Organizations and CROs are becoming more value conscious. Centralizing the translation of clinical trials can cut costs through effective terminology management and workflow consolidation.

First, using one centralized Translation Memory (TM) eliminates redundancy in terminology and phrases, reducing the cost of clinical trial translations. And, when a CRO is using one, instead of numerous TMs, the process is streamlined.

Also, when using one LSP, organizations lower administrative costs as they are only responsible for managing one group of linguists and project managers. Leveraging only one LSP means reduced meetings, time spent on a contract and the added benefit of consolidated reporting.

Cutting Timelines

Every day a clinical trial is delayed means money lost. Doctors and patients usually want patient information right away when a trial is taking place, and expediting the translation process is a necessary component of translating clinical documents.

In a centralized model, research organizations will benefit from web-based project management and client review systems to speed up translations. At the same time, utilizing one TM will add to efficiency as the number of words needed to be translated will go down.

Using online workflow portals automates the translation process, therefore increasing turnaround times.

Less Expense, Increased Efficiency

Centralizing the translation of clinical trials with a reputable LSP can eliminate redundancy and rework, ultimately saving time and money. And in an industry where regulation and efficiency is key, centralization is an important aspect of clinical trial translation.

ULG will host a webinar on the importance of centralizing the translation of clinical trials on April 20. If you are interested in attending, please register here.

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Life Sciences Strategy

Jake Schild

Jake Schild

A former newspaper reporter and native Minnesotan, Jake Schild is a staff writer in the marketing department at ULG.

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