Clinical trial translation has become a strategic part of European regulatory compliance. Since the full application of Regulation (EU) 536/2014 and centralised management through the Clinical Trials Information System (CTIS), consistency in documentation has become a matter of linguistic quality and regulatory risk. A term...
In many projects, multilingual informed consent is the document that ultimately determines whether your timeline stays on track or falls apart. Few things are more frustrating for a CRO than having everything ready for site activation, only to become stuck because the consent forms in...
More and more clinical trials depend on what patients report: symptoms, quality of life, and the impact of treatment on their daily lives. These are PROs in clinical trials, and in 2026 they sit at the centre of the regulatory conversation. The problem is that a...
CROs live surrounded by documents: protocols, amendments, investigator manuals, consent forms, recruitment materials, safety reports, scientific publications and more. When each country, each team or each provider manages translations "in their own way", the result is predictable: inconsistencies, rework, data at risk and uncontrolled costs. Centralised...
In a multinational clinical trial, it is enough for a single sentence to be poorly translated for the whole study to falter: misinformed patients, invalid data, regulatory delays running into millions of dollars. Medical and pharmaceutical translation is no longer an "extra," but a central...
Imagine you’ve got everything ready to launch an international clinical trial… and a single ambiguous sentence in the translated protocol delays approval by three months. It happens more often than you’d think. In biomedical research, one word can mean the difference between an approved study...
Regulatory translations are a critical component of the medicinal product authorisation process in the European Union. If the preparation or review of language versions is poorly managed, by failing to follow official templates, skipping specialised linguistic review, or missing submission deadlines, the validation of the...
Conducting clinical trials is a highly complex and demanding process. Coordinating multiple teams, ensuring compliance with strict regulations and maintaining clear communication across borders are just some of the challenges that clinical research organisations face. In this context, e-learning materials have emerged as a crucial...
Digital transformation is redefining the way patients interact with healthcare - from managing appointments and accessing test results to receiving diagnoses and following treatment plans. And in this new landscape, language is more than just a communication tool: it is about inclusion, equity and safety....
Translating an app is not a piece of cake. It is a mixture of many things and requires a thorough understanding of the terminology, the healthcare context and, above all, the target patients’ culture. This was the challenge that Roche, one of the world's leading...