Services- translation and Cultural Adaptation

Ensuring high-quality, culturally appropriate PRO implementation across global trials

Accurate, culturally sensitive translation of Patient-Reported Outcome (PRO) measures is essential for generating reliable, comparable data in multinational clinical trials. Poor translation can introduce bias, compromise endpoint integrity, and undermine regulatory acceptance.

At Bottomley Consulting Group (BCG), we provide expert support in the translation and cultural adaptation of PRO instruments—ensuring they maintain their original meaning, psychometric properties, and relevance across diverse patient populations.

🔬 Aligned with International Standards

We follow the gold-standard methodologies recommended by:

ISPOR (International Society for Pharmacoeconomics and Outcomes Research)

ISPE and FDA/EMA guidance on COA implementation

International frameworks for linguistic validation and back-translation

These standards help ensure that translated measures are:

✅ Linguistically accurate

✅ Psychometrically valid

✅ Culturally appropriate for each target population

🧠 Our Services Include:

Guidance on translation vendor selection and process oversight

Review of forward and back-translations, harmonization, and reconciliation steps

Quality control of cognitive debriefing interviews and final version approval

Advisory on documentation required for regulatory submission and audit-readiness

Why It Matters

Regulators and HTA bodies increasingly expect clear evidence that PRO instruments have been translated and adapted following recognized best practices. Inconsistent translations can delay submissions, compromise data quality, or call endpoint credibility into question.

With BCG’s support, you can be confident that your PRO data stands up to global scrutiny.

Let’s Get Your Measures Ready for the World

Whether you’re translating a validated tool or adapting a custom item set, Bottomley Consulting Group helps you navigate the complexities of multilingual implementation—without compromising scientific integrity.

📩 Contact Us to discuss how we can support your trial’s translation and cultural adaptation strategy.