How Expert Translations Drive Regulatory Success in Global Clinical Trials
Bringing a new drug or medical device to market is a rigorous process that involves strict regulatory oversight, detailed documentation, and careful coordination across global teams. Amid the many moving parts, one factor is often underestimated—yet it plays a decisive role in determining whether a clinical trial proceeds smoothly or encounters costly delays: translation accuracy.
In an increasingly globalized research environment, the ability to communicate clearly and precisely across languages is essential. A single mistranslation in an informed consent form or regulatory submission can lead to significant compliance issues, regulatory setbacks, or even trial rejection.
With agencies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) enforcing strict standards, life sciences companies and clinical research organizations (CROs) cannot afford to overlook the importance of high-quality translations.
The Role of Accurate Translations in Regulatory Compliance
Regulatory authorities require comprehensive documentation to evaluate the safety and efficacy of new therapies. Key materials—including informed consent forms (ICFs), investigator brochures, clinical study protocols, and adverse event reports—must be translated with a high degree of accuracy to comply with regulatory standards. Any errors in translation can lead to misinterpretation, putting patient safety at risk and potentially compromising the integrity of the trial.
This issue is especially important given ongoing concerns around language barriers in clinical trials. One study found patients with limited English proficiency signed consent forms in a language different from their primary language in 31.9% of industry-sponsored studies and 65.9% of non-industry-sponsored studies. These findings highlight the urgent need for accurate translations to support true informed consent and uphold ethical standards in clinical research.
The Financial Costs of Translation Errors
Translation errors can also carry significant financial consequences. Documentation issues that cause delays in clinical trials may cost sponsors anywhere from $600,000 to $8 million per day, factoring in lost revenue from potential drug sales. These delays not only impact budgets but also postpone access to potentially life-saving treatments for patients.
The direct daily cost of running a clinical trial is estimated at approximately $35,000. As such, even minor setbacks—especially those stemming from translation inaccuracies—can substantially increase operational expenses and extend time-to-market.
More importantly, these delays also postpone patient access to potentially life-saving treatments. This underscores the importance of working with experienced, reliable language service providers who specialize in clinical trials and understand the high standards required for regulatory compliance and patient safety.
How Expert Translations Accelerate Approval Processes
Successfully working with complex regulatory environments requires more than accurate documentation—it demands deep expertise in language and compliance. For CROs and life sciences companies conducting international trials, partnering with a trusted language service provider specializing in clinical trial translations is critical.
Choosing a provider like DTS Language Services who is certified to ISO 17100 standards ensures that translations follow strict quality assurance protocols and industry best practices. This level of oversight not only supports regulatory compliance but also reduces the risk of delays and costly rework.
At DTS, each Clinical Trial project is overseen by a dedicated project manager with extensive experience in clinical trials. Every project is assigned a transparent and accurate target completion date. Clients can maintain a direct line of communication with their Project Manager to receive real-time updates on project status. We also harness cutting-edge translation portal technology to support efficient communication and accurate progress tracking.
High-quality translations do more than meet regulatory requirements—they contribute directly to clinical trial success. By incorporating expert translation services early in the process, life sciences organizations can significantly reduce approval timelines, avoid costly setbacks, and bring new therapies to market more efficiently.
When the stakes are high, and every detail matters, investing in precise, high-quality translations is not just a regulatory necessity—it’s a strategic step toward faster approvals, greater global reach, and better patient outcomes.
