Clinical Research
Trial Operations &
Data Collection
This is where all the work our clients have done at the preclinical and recruitment stages is put into action. The trial begins in earnest, and our clients must ensure everything is conducted safely, in compliance with regulations, and as per protocols. They need to collect and assess data, keeping a careful eye on participants, sites, and endpoints. And ultimately do all they can to ensure their trial thoroughly tests and proves their product’s safety and efficacy. We help them every step of the way, translating and version-controlling operational documentation, localizing patient-facing materials, and ensuring all language versions of regulatory documents remain up to date.
Specific Ways We Can Help.
Regulatory submissions
- We help our clients to ensure their documentation remains up to date and submissible across every trial language.
Investigator brochures (IBs) & site training materials
- We translate original materials and updates, with careful version control. For training materials, we offer voiceover and subtitling, as well as an in-house DTP service.
Case report forms (CRFs)
- It’s crucial that these comprehensive records capture data clearly and consistently across global trial sites. Translation is key to achieving this for all trial teams and participants.
Patient diaries & surveys
- Patient diaries and surveys contain data that can be integral to a trial’s success. Getting the language right – in terms of clarity and appropriateness – is important in capturing sometimes emotional, personal information.
Overcoming Trial Operations Challenges.
One of the key challenges of trial operations is ensuring everyone’s safety in such a dispersed environment. We help our clients to translate essential materials like investigator brochures and site training, and help keep them up to date across all languages, so everyone has the same understanding of requirements and best practice.
Gathering and interpreting data from a vast array of sources and participants is a crucial part of the trial process. We enable our clients to collect the information they need regardless of language or culture, through localization of items like patient diaries, surveys, and case report forms.
The data collected and any consequent changes to the trial need to be continuously documented for safety and regulatory purposes. We help our clients to stay on top of their multilingual documentation throughout the course of their trial.
Why Work With Us.
Trusted by organizations all over the world
Case Studies.
FAQs.
The costs and timelines for translation vary depending on factors like languages, volumes, and service level. We create a quote for each new project, which includes details of costs and turnarounds. If you would like us to create a quote for you, please get in touch with the team.
That’s great news! Please complete our contact form and the team will be in touch to arrange an initial conversation.