Accurate and Timely Translation of ICFs for CRO

Novotech is a global Contract Research Organization (CRO) headquartered in Australia, supporting clinical trials across multiple regions and therapeutic areas. As Novotech expanded its clinical research activities, particularly within the U.S., the organization needed to translate Informed Consent Forms (ICFs) into multiple languages to support enrollment of non-English-speaking participants. Given the strict regulatory and approval requirements associated with informed consent documentation, Novotech required a partner with deep therapeutic and regulatory expertise, the ability to work efficiently across multiple study sites, and a proven track record of delivering accurate, timely, and compliant translations.

The Problem

Novotech needed to translate ICFs into multiple languages to ensure eligible patients could be enrolled without delays. These translations were critical to meeting regulatory requirements and maintaining study timelines across geographically distributed sites. The challenges included:

• Translating highly regulated Informed Consent Forms into multiple languages
• Executed updates around quickly, minimizing delays across study sites
• Ensuring translations were approved quickly within a strict regulatory review process

Any delays in translation or approval could directly impact patient enrollment which is a critical success
factor for clinical trials.