Overcoming Clinical Trial Translation Challenges in Multi-Country Studies

The Challenge

Global clinical trials involve multiple countries, languages, and regulatory requirements. Translation errors can compromise patient safety and data integrity.

Key Challenges

1. Informed Consent Forms

ICFs must be linguistically validated to ensure patients truly understand what they're consenting to.

2. Patient-Reported Outcomes

PRO instruments require rigorous linguistic validation following ISPOR guidelines.

3. Regulatory Submissions

Different countries have different submission requirements and languages.

4. Timeline Pressure

Clinical trials operate on tight timelines with little room for translation delays.

Solutions

Linguistic Validation

Follow the ISPOR 10-step process for PRO instruments to ensure conceptual equivalence.

Cognitive Debriefing

Test translations with native speakers from the target patient population.

Translation Memory

Build and maintain translation memory for consistency across documents and studies.

Experienced Partners

Work with LSPs who specialize in life sciences and understand regulatory requirements.

Case Study

We recently supported a Phase III oncology trial across 15 countries and 12 languages, delivering all translations on time with zero regulatory queries.

Conclusion

Success in clinical trial translation requires expertise, process, and partnership.