In clinical translation, even a single term can impact study procedures—making precision absolutely critical.

SORA’s clinical team has extensive experience translating a wide range of documents, including clinical trial protocols, investigator’s brochures (IB), clinical study reports (CSR), and statistical analysis plans (SAP).

We go beyond linguistic conversion, accurately reflecting both the intent of the study and applicable regulatory requirements. Our translations are aligned with ICH, MedDRA, and ISO terminology, as well as guidelines from regulatory authorities such as MFDS, FDA, and EMA. Maintaining the overall structure and flow of each document, the content is carefully crafted to ensure clarity for both regulators and operational teams.

This depth of experience enables us to support pharmaceutical companies, CROs, hospitals, and research organizations with reliable, submission-ready translations.