Translation for Life Sciences : our experience with the Pharmaceutical and CRO world

A dedicated Project Management team works with you to define solutions and procedures that meet your translation needs and to manage all your projects to ensure they are delivered on time.

Our extensive network of language professionals enables us to quickly react to urgent translation requests and manage translation peaks. In parallel, our ongoing recruitment programme means that we can adapt our network to market trends and recruit new translators for new or more frequently needed language combinations

In addition, our internal employees and network of professionals are trained to adapt to changes in the content or delivery date during an ongoing project.

Clinical trials are increasingly conducted on an international basis. There are many advantages to international trials, but they also generate additional challenges for the CRO.

You have to get your documents ready on-time for submission in each country, accurate in all languages, stored in a secure environment, with clear tracking and visibility of the work in progress.

Ubiqus can help you navigate these steps smoothly.

We provide all the services you need throughout the lifecycle of your study: from early stage to post-marketing phase. Furthermore, we can accommodate your specific requirements:

• Target audiences: patient and professional content
• Countries involved: extensive coverage of a range of language combinations
• Therapeutic areas: experts in a range of therapeutic areas
• Content types: Informed Consent Form (ICF), Protocol, Protocol Synopsis, Investigator Brochure, Patient Diary, Questionnaires, Regulatory Affairs and Ethics Committee Correspondence, Contracts, Serious Adverse Event (SAE) and more
• Text adaptation: reworking medical texts for a lay audience
• Formats: all editable formats, PDFs and handwritten documents

Our internal standard operating procedures combined with the latest technology ensure successful outcomes: your translation is in good hands.

We understand the importance of patient safety. For this reason, we ensure we have the regulatory and industry-specific knowledge to translate all your regulatory documents accurately and in compliance with regulatory agencies (FDA, EMA, …).

We regularly translate Product Information Leaflets (PILs), Labels, Packaging, Summaries of Product Characteristics (SPCs) and Regulatory Correspondence.

To meet the local regulatory standards, we comply with Quality Review Documents (QRD) template guidelines, as published by the EMA.

We also comply with the Medical Dictionary for Regulatory Activities (MedDRA) and Good Clinical Practice (GCP) guidelines, as published by the ICH.

We use the latest technology to ensure that the client-specific style guides, templates and glossaries we create maximise quality, consistency and compliance.

We provide a rapid and reliable service for the translation of Serious Adverse Event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) reports.

• Translation of e-Learning modules
• Marketing translations
• Interpretation services
• Machine translation
• Post-editing
• Linguistic validation
• Transcription
• Sworn translations
• Subtitling/Audiovisual