Trials Are On The Clock 

In clinical research, time isn’t just a resource, it’s a critical driver of success. Timely site start-up activities, expedient Clinical Trial Agreement (CTA) approvals, and fast regulatory submissions are essential to maintaining trial momentum. Delays at these stages can cascade into missed milestones, such as First-Patient-In (FPI) timelines, jeopardizing the entire study. 

But hidden bottlenecks, like translation delays, can quietly erode trial momentum. While they often go unnoticed in early planning, they show up when it counts: during the Clinical Trial Application, patient enrollment, or Institutional Review Board (IRB) and Ethics Committee approval. 

If language services aren’t done right the first time, the consequences are significant: delays in regulatory approvals, setbacks in patient enrollment, missed study milestones, increased friction with sponsors, and damage to the contract research organizations’ (CROs) reputation. 

The Real Cost of Translation Delays

Translation in clinical trials isn’t just a checkbox. It’s a critical component that directly influences the pace and success of the trial. Here’s how:

• Missed IRB or Ethics Committee Deadlines: Noncompliant or delayed translations can stall local approvals, holding back site activation. 

• Delays to FPI: If patient-facing materials aren’t translated accurately and on time, patient enrollment is delayed, stalling the entire study. 

• Missed Regulatory Submission Cycles: Fixing poor translations often means missing submission windows. In some cases, sponsors may wait months for the next slot. 

The Cost of Clinical Trial Delays 

$800K per day – A widely cited Tufts CSDD figure that has shaped industry benchmarks for over a decade. 

$500K per day (average) – Tufts’ latest research (2024) refining the estimate across therapeutic areas. 

Up to $1.4M per day – In high-value indications like oncology or immunology. 

👉 Every day of delay means lost revenue, lost data, and patients waiting longer for treatment. 

 (Tufts CSDD)

When Language Quality Compromises Data Integrity

Speed alone isn’t enough. Precision and cultural relevance are non-negotiable. Patient-facing materials like brochures, informed consent forms or patient-reported outcomes (PROs) must be clear, accurate, and culturally appropriate. Poor translations lead to: 

• Misunderstood Instructions: Patients may not follow trial protocols correctly. 

• Inaccurate Patient Responses: Miscommunication can lead to flawed data. 

• Compromised Data Integrity: Errors in translated content won’t stand up to regulatory scrutiny. 

A staggering 60% of submission delays stem from documentation quality issues, many of which are tied to translation errors. 

When translation errors occur, trial managers shouldn’t have to step in to fix them; that’s where expert partners make the difference. 

Reputation at Risk

In clinical research, reputation is everything. Sponsors and partners stake their names on every trial. 

Mistakes in documentation, missed deadlines, or public-facing errors don’t just slow down timelines; they undermine trust, credibility, and future opportunities for both CROs and sponsors. 

• Escalations: Preventable translation issues reflect poorly on your organization. 

• Increased Regulatory Scrutiny: Inconsistent, unclear, or non-compliant content invites deeper regulatory inspection. 

• Public Exposure: Errors revealed during audits or inspections can result in reputational damage that’s hard to recover from. 

What High-Performing Teams Do Differently

Top-performing clinical trial teams treat translation as a strategic input, not an afterthought. They: 

1. Prioritize First-Time-Right Quality: Reducing rework and resubmissions saves time and resources. 

2. Choose Partners with Regulatory Expertise: Working with ISO-certified translation providers ensures compliance and consistency. 

3. Integrate Translation Workflows: Tools like Veeva Clinical Vault can streamline processes, maintain version control, and reduce manual errors. 

This proactive approach protects timelines, ensures submission readiness, and minimizes last-minute escalations. 

Make Translation an Accelerator, Not a Bottleneck

In clinical trials, every delay comes at a cost: 

• Speed protects revenue. 

• Quality protects data. 

• Precision protects your reputation. 

The most successful teams understand this and prioritize choosing the right partners. 

Are you ready to eliminate translation bottlenecks and accelerate your clinical trials? Every delay means lost data, lost revenue, and lost time for patients who can’t afford to wait. Let’s ensure your next trial moves forward without delays. 

 Contact Welocalize today to learn how we can help!