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COA & Linguistic Validation: End-to-End Global Solutions for Clinical Trials

Accelerate your global clinical trials. From COA licensing and linguistic validation to eCOA migration, we can help you launch faster, avoid regulatory delays, and ensure globally consistent, patient-friendly content, in over 500 language pairs.
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25% Faster Delivery
Beating industry timelines, even in complex trials

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500+ Language Pairs
Global reach across every major study region

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100% Cost Transparency
Clear budgets with KPI-backed reporting

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40% Less Admin
Fewer manual tasks, more focus on your trial

Abbott
Johnson & Johnson
Steris
Lilly
Novo Nordisk
Novartis
Allergan

75% of Clinical Trials experience delays,  many caused by mismanaged COA licensing, incomplete linguistic validation, or poorly planned eCOA implementation. Acolad provides simplified full-service COA management, ensuring speed, IP compliance, and regulatory alignment across all languages and platforms.

Our Linguistic Validation Process

Simplify the complex journey of linguistic validation for your clinical trials. We deliver end-to-end management, working closely with sponsors and study teams, copyright holders/developers, CROs, and eCOA vendors. This integrated Clinical Outcome Assessment (COA) Linguistic Validation process ensures full compliance, data integrity across all languages, and budget transparency. By running workflows for licensing, linguistic validation, and eCOA in parallel, we deliver faster timelines.

Expert COA Licensing

COA licensing is a critical, often overlooked step that impacts trial timelines. Our experts streamline the entire process, reducing compliance risks and accelerating study start-up. We begin with a strategic consultation, aligning licensing with your study objectives. Our team proactively evaluates copyright holder requirements from established relationships, assesses availability, and guides you through every step.

At the same time, our audit-ready process also ensures full visibility with clear reporting on licensing terms, translation needs, and timelines, delivering tailored support, faster approvals, and inspection readiness. 

  • icon-check-light-bg Strategic protocol review
  • icon-check-light-bg Established relationships with copyright holders and developers
  • icon-check-light-bg Full audit-ready documentation and cost transparency
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COA Licensing Process

Key Considerations for COA Licensing Process Success

These critical steps can help you ensure compliance and avoid jeopardizing clinical trials.

Linguistic Validation for COA Success

Ensure your COA instruments are culturally appropriate and easily understood by patients worldwide. With 18+ years of experience, our linguistic validation service delivers accurate, submission-ready validated translations, aligned with FDA PRO guidance and ISPOR Good Practice Guidelines. This FDA-recommended process supports patient understanding and ensures stronger data integrity.

  • icon-check-light-bg Project Setup: Planning and Preparation
  • icon-check-light-bg Harmonization: Translate, reconcile, and review
  • icon-check-light-bg Cognitive Debriefing: Native-speaker interviews to ensure cultural and conceptual relevance
  • icon-check-light-bg Final Delivery: Validated translations ready for submission or COA Library integration
  • icon-check-light-bg Audit-ready: Full documentation aligned with regulatory standards
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High-Quality eCOA Migration

As leaders in linguistic validation and electronic Clinical Outcome Assessment best practices, we efficiently manage eCOA migration by teaming up with expert vendors to provide seamless integration and support. We handle screenshot translations, layout reviews, and developer coordination to deliver accurate, consistent, and submission-ready digital COAs across languages and countries.

With our centralized COA Library, we help you manage all your clinical trial instruments by keeping them updated, monitoring their use, and quickly handling all translations and digital setup.

  • icon-check-light-bg eCOA Migration
  • icon-check-light-bg Screenshot review and certification
  • icon-check-light-bg Developer review
  • icon-check-light-bg Deliver certified eCOA versions
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Your Complete COA Linguistic Validation Journey

Strategic, complaint and efficient
COA Linguistic Validation Workflow

Tailored for COA Specialists, CROs, eCOA Vendors and Global Clinical Teams

Whether you're a COA specialist, CRO clinical manager or eCOA expert, Acolad simplifies global study execution—especially in multilingual, multi-country trials.
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Sponsors of all therapeutic areas

Biotech & Pharma and Medical Devices
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Public Health & Nonprofits

“The success of global clinical trials hinges on clear, compliant patient data. With our fully managed linguistic validation process – from licensing to being eCOA ready – we bridge the language and technology gap, so you can reach your research goals with complete confidence.”

kajal-chopra


Kajal Chopra
Acolad, Senior Licensing & COA Expert

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AI-Powered Precision. Human-Led Assurance.

For your clinical content, we combine the power of AI with essential human expertise through a tech-agnostic approach tailored to your needs. We responsibly integrate GenAI and NMT, enhancing translation speed and consistency while guaranteeing expert review and full compliance. Our secure, ISO-aligned systems support the latest regulatory guidance from FDA, EMA, and ISPOR.

This allows our AI solutions and connectors to seamlessly boost decision-making and efficiency directly within your existing COA and linguistic validation workflows. You get integration that supports your licensing and eCOA needs directly within your owned platforms and systems.

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Ready for Expert COA Linguistic Validation in Your Global Trials?

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Frequently Asked Questions

New to COA & Linguistic Validation for Clinical Trials? We have answers.

Is your process compliant with regulatory standards?

Absolutely. Our processes are designed with the strictest regulatory requirements in mind. We are fully compliant with FDA PRO Guidance and EMA Requirements, and we also adhere to ISPOR Best Practices. Our systems are ISO-aligned, including ISO9001:2015 (QMS), ISO17100:2015 (Translation), ISO18587:2017 (MTPE), ISO13485:2016 (Medical Device), and ISO27001:2013 (Data Security). This rigorous approach ensures your studies meet the highest standards, providing you with regulatory confidence and audit-ready documentation.
How long does the COA validation and licensing process take?

We understand that timelines are critical in clinical trials. While the exact duration can vary depending on the complexity of the COA and the number of languages, Acolad's streamlined processes are designed for speed. Our approach reduces common COA licensing delays and accelerates linguistic validation timelines, ensuring faster approvals. We aim to deliver up to 25% faster than industry averages by running workflows for licensing, linguistic validation, and eCOA in parallel. Many clinical trials experience delays, with approximately 75% facing setbacks due to regulatory or licensing challenges, often caused by mismanaged COA licensing or incomplete linguistic validation. We proactively address these challenges. Our strategic approach to COA licensing, which begins early in the protocol design phase, helps prevent unforeseen difficulties and accelerates study start-up by securing licensing approvals before study initiation. 
What are the typical steps in the COA linguistic validation process?

Our linguistic validation process is comprehensive and aligns with FDA PRO guidance and ISPOR Good Practice Guidelines. Here's a simplified overview of the key steps:

  1. Project Setup - Planning and preparation
  2. Harmonization - This stage includes subject matter expert review, in-country review, client review, and optional developer review.
    • Two independent forward translations
    • Reconciliation into a harmonized version
    • Back-translation or reconciled translation
  3. Cognitive Debriefing - We conduct interviews with native speakers to ensure cultural and conceptual relevance and gather feedback.
  4. Finalization - This step includes a final subject matter expert review, optional developer review, and reconciliation to produce the linguistically validated translations ready for submission or integration into your COA library.
What makes Acolad different from other COA validation providers?

Acolad offers an efficient COA management experience for your global trials. We provide end-to-end solutions, encompassing COA licensing, linguistic validation, and eCOA migration, simplifying a complex process. Our key differentiators include: 

  • Accelerated Timelines & Efficiency: We deliver up to 25% faster than industry averages by running workflows in parallel, reducing administrative burdens and avoiding costly delays.
  • Regulatory & Copyright Expertise: Our processes are compliant with FDA, EMA, and ISPOR guidelines. We also leverage established relationships with copyright holders to accelerate licensing and ensure compliance.
  • Dedicated Experts & Transparency: Each project benefits from a dedicated COA expert, ensuring personalized support and 100% cost transparency through clear reporting. We also combine AI with human expertise for precision and assurance.