10 Dic How CROs benefit from centralised translation workflows

CROs live surrounded by documents: protocols, amendments, investigator manuals, consent forms, recruitment materials, safety reports, scientific publications and more. When each country, each team or each provider manages translations «in their own way», the result is predictable: inconsistencies, rework, data at risk and uncontrolled costs.

Centralised translation workflows have emerged precisely to resolve this chaos and turn medical and pharmaceutical translation into an efficiency lever for CROs.

The problem of fragmented translation in CROs

In many projects, the CRO coordinates various local vendors, researchers’ «trusted» translators and internal tools that are not connected to each other. This generates:

• Different terminology between countries for the same clinical concepts.
• Duplicate or non-existent translation memories.
• Lack of real visibility on what has been translated, how much has been spent and in what timeframes.

Industry analyses indicate that translation costs in clinical trials increase significantly when there is no centralised strategy and efforts are duplicated in different phases of development.

In parallel, the pressure to shorten times is enormous: most trials suffer delays and each day of delay can cost hundreds of thousands or even millions of euros.

What is a centralised translation workflow

A centralised model does not mean «one translator for everything», but a coordinated system where:

• There is a central provider or platform that manages translations for all countries.
• Translation memories and global glossaries, shared by all teams, are used.
• Communication between CRO, sponsor, translators and reviewers is structured on secure cloud platforms, with version control, comments and traceability.
• Standard processes are defined for critical documents (protocols, consents, PROs, etc.) that include medical review and, when appropriate, linguistic validation.

Within this framework, the translation of medical articles derived from the trial —for example, publications in international journals— also benefits from consistent terminology and aligned review processes.

Benefit 1: Scientific and terminological consistency

Terminological consistency is key to ensuring data comparability across countries. A centralised workflow allows for alignment across all versions of study documents and related scientific documentation.

In complex projects, this approach translates into:

• Identical inclusion and exclusion criteria in all countries.
• Adverse events described with the same terminological precision.
• Consistent materials between medical and pharmaceutical translation of protocols, labels, manuals and scientific manuscripts.

Benefit 2: Cost savings and reduced lead times

Centralising not only improves quality, but also reduces costs. Grouping volumes into a single workflow allows:

• Reuse of segments already translated using translation memories, instead of starting from scratch in each country.
• Avoidance of retranslations of slightly modified versions of the same document.
• Optimisation of review times by working on standardised templates and workflows.

In a context where each additional month of trial can cost millions, reducing even a small percentage of translation-related delays can mean considerable savings.

Benefit 3: Governance, security and compliance

CROs must demonstrate to sponsors and regulators that their processes are traceable and auditable. A centralised translation workflow facilitates:

• Access control and permissions on sensitive documents.
• Record of who translated, reviewed and approved each version.
• Generation of certified medical translation certificates for documents that require it (for example, informed consents or documentation submitted to regulatory agencies).

This reduces compliance risks and facilitates inspections, both regulatory and internal quality.

Benefit 4: Scalability and safe use of AI

The volume of healthcare content is growing exponentially. Without a strategy, trying to scale solely with machine translation tools can trigger errors, rework and inconsistencies.

A centralised workflow allows:

• Integrate AI and machine translation within a controlled architecture, with specialised human post-editing.
• Decide which types of content (low-risk internal communications, for example) can benefit from AI and which (consents, PROs, regulatory reports) require fully human medical and pharmaceutical translation.

For CROs, this means being able to handle more projects, in more languages, without sacrificing quality or patient safety.

How to implement centralised translation workflows in a CRO

To move from a fragmented model to a centralised one, CROs can follow several steps:

1. Map all multilingual content across the trial lifecycle: from materials for ethics committees to the translation of medical articles reporting results.
2. Select expert partners in medical and pharmaceutical translation, with demonstrable experience in clinical trials, linguistic validation and interaction with regulatory agencies.
3. Define global glossaries and style guides approved by medical teams to ensure terminological consistency across all countries.
4. Implement a central platform (TMS/LMS) that centralises projects, memories, approvals and certifications, with robust audit and security capabilities.
5. Measure results: delivery times, reuse percentage, number of translation-related incidents, impact on centre activation times, etc.

For CROs, translation is no longer just a checkbox to tick off the study’s to-do list. With centralised translation workflows geared toward medical and pharmaceutical translation, it becomes a clear competitive advantage: more efficient operations, more reliable data, better relationships with sponsors and less friction with regulators.