We work closely with CROs to support global clinical operations, ensuring that multilingual documentation remains consistent, compliant, and ready for regulatory scrutiny.
Our expertise includes:
- Clinical trial documentation Protocols, amendments, IBs, ICFs, and site‑facing materials.
- Study start‑up materials Recruitment content, site manuals, and training documentation.
- Safety and pharmacovigilance content ICSRs, SUSAR reports, DSURs, and safety narratives.
- Data management and biostatistics materials CRFs, data dictionaries, statistical analysis plans, and outputs.
- Operational documentation Monitoring reports, site correspondence, and project communications.
- Regulatory submissions Global filings prepared in alignment with regional authority expectations.
By supporting CROs with accurate, timely, and compliant translations, we help streamline global clinical operations and reduce the risk of delays or inconsistencies. Our expertise ensures that every document—from study start‑up to close‑out—meets the rigorous standards required for successful multinational trials and regulatory submissions.
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