We believe that global clinical research has reached a tipping point. Studies now span more countries, more languages, and more regulatory environments than ever before, and at the same time, clinical trial sponsors are expected to move faster, engage patients more effectively, and meet rising expectations for transparency and quality.

This convergence has forced a fundamental question. How can clinical teams scale communication across borders without adding risk or delay? AI‑assisted translation is emerging as a clear answer.

With today’s clinical trials, translation touches nearly every operational milestone. It influences how quickly clinical sites activate, how confidently patients consent, how clearly regulators evaluate submissions, and how consistently updates are managed across regions. For years, translation workflows were treated as transactional. Documents were sent out, returned, reviewed, and reworked. That model worked when clinical studies were smaller and timelines were more forgiving, but it no longer works under the weight of today’s global programs.

What teams need now is a system that treats translation as a core operational capability.

Why AI Fits This Moment

AI adoption across pharma and biotech has accelerated in recent years, particularly in regulated content workflows. Organizations are using AI to support evidence synthesis, safety monitoring, and regulatory documentation. Translation naturally follows this progression, and Cliniphai’s Athena is leading the way in this space. 

AI‑assisted translation platforms like Athena bring structure to a process that was historically fragmented. Instead of relying on manual handoffs and disconnected vendors, teams gain a unified environment where terminology, context, and review cycles are managed consistently.

When paired with human expertise, AI helps reduce repetitive work, surface risks earlier, and maintain alignment as documents evolve. The result is speed with control, not speed at the expense of quality.

One of the most meaningful shifts enabled by AI is how compliance is handled. In traditional workflows, compliance checks often happen late in the process, after translation is complete. That approach invites rework. Instead, AI‑enabled systems allow compliance considerations to be embedded earlier. Terminology standards, regional requirements, and audit trails are built into the workflow rather than layered on afterward. 

What Forward‑Looking Teams Are Doing Differently

Recent industry collaborations illustrate how translation fits into a broader clinical and regulatory ecosystem. When evidence synthesis platforms and localization workflows operate together, teams can move seamlessly from data generation to submission‑ready materials. This approach supports global health authority engagement and maintains consistency throughout.

At Cliniphai, we find the teams who treat translation as a strategic asset rather than a downstream task are more successful overall. Organizations like this who are preparing for the next generation of clinical research are rethinking how translation fits into their operations by doing the following:

• Planning localization alongside protocol development
• Using centralized systems, like Athena, to manage updates and reviews
• Engaging language experts with clinical and regulatory experience
• Treating translation as an ongoing process rather than a one‑time event
  

These seemingly simple shifts are currently allowing teams to scale in a controlled way. To help in the evaluation of AI‑assisted translation, Cliniphai recommends starting with a few simple questions, including:

• Are translation requirements defined early in study planning?
• Are updates tracked consistently across regions? How so?
• Is terminology controlled across documents and languages?
• Are compliance requirements visible throughout the process?
• Can progress be monitored in real time?
  

As studies continue to globalize, Cliniphai believes that the future of clinical research will belong to teams that treat language translation and localization as infrastructure, not an afterthought.

For questions on any of the topics covered here, connect with the team.

Clinical trials operate on tight timelines, and a recent article in JAMA Network found that more than 70 percent of clinical trials in its study were delayed. As pharma and biotech professionals, it’s no secret that every milestone, from regulatory submissions to patient enrollment, is mapped against a ticking clock. However, any and all delays should be avoided, as they can compound rather quickly.

One hidden factor that continues to cause costly delays is slow, inefficient clinical trial translation and localization.

Language localization is critical to nearly every clinical trial across the globe. Patient-facing materials, site instructions, regulatory documents, investigator communications, and the like, must all be accurately translated into a variety of languages. When these translations are delayed, the impact is felt across every part of the clinical trial process.

What’s Really at Stake?

Translation delays can stall a clinical trial in ways that are not always obvious, including the following:

• Missed enrollment windows: If patient-facing materials are not ready and available in the required local languages, recruitment often comes to a stop.
• Regulatory rework: Poor or late clinical trial translations can often trigger additional questions, rejections, or back-and-forth with ethics committees and health authorities.
• Site frustration: When investigator brochures (IBs), clinical study protocols, or training documents are not localized on time, site teams are often left waiting, confused, or disengaged.
• Vendor cost overruns: Unplanned delays have the potential to come with expedited fees or added project management hours to catch up.

To help quantify this, the Tufts Center for the Study of Drug Development (Tufts CSDD) recently determined that the “the value of a single day of delay is worth approximately $800,000 in unrealized or lost prescription drug sales and $40,000 in direct daily clinical trial costs.”

A Better Path Forward

Clinical trial sponsors are increasingly turning to technology platforms designed to address these gaps. With AI-enabled localization tools and structured human-in-the-loop (HITL) models, like Athena, sponsors can gain both speed and accuracy to help curb translation delays in clinical trials. The ability to move from core materials to compliant translations with full transparency gives teams a clearer runway to hit their enrollment and submission goals.

Within Cliniphai, experts have seen firsthand how small changes in translation and localization planning can drive measurable gains across clinical study timelines. Based on work with sponsors and global language experts like GRC, here are a few practical strategies for avoiding translation delays:

• Begin localization discussions early to help streamline both regulatory and patient-facing workflows.
• Centralize translation activities on a single platform to prevent disjointed vendor handoffs and manual file exchanges.
• Use specialized linguists who understand clinical content.

Translation delays in clinical trials often fly under the radar until they force a trial stoppage in a given country. By recognizing the impact upfront and adopting a proactive localization strategy, clinical teams can stay on pace and keep these much-needed programs moving forward across borders.

For questions on any of the related content within this article, connect with the team here.