Case Study: Cara Therapeutics achieves FDA-compliant global trial translations with Acolad

Cara Therapeutics secures FDA approval in 2021 with Acolad

Cara Therapeutics, an early commercial-stage biopharmaceutical company, faced the challenge of managing translations for a global Phase III clinical trial for their drug Korsuva™. With little internal experience, they needed a language service provider to ensure FDA-compliant translations, manage linguistic validation, and navigate the regulatory requirements across eight countries. They partnered with Acolad for its translation and subject matter expertise.

Acolad implemented a customized clinical trial production system, ISO-certified processes, and a dedicated team to manage the translations with quality and efficiency. This solution provided full visibility and streamlined collaboration with Cara’s CRO. As a result, the study was successfully completed, and Cara Therapeutics received FDA approval for Korsuva™ Injection in 2021. The successful partnership continues as Cara trusts Acolad with linguistic validation for new global studies.

Cara Therapeutics