Support for Clinical Trials
We will support you in the organisation of clinical trials by coordinating all necessary language services. Our services include, for example, the following activities:
- Creation of information brochures based on your data
- Testing and verification of the comprehensibility of English and German texts based on scientific methods and procedures with the language software TextLab from H&H Communication Lab GmbH - Institute for Comprehensibility
- Organisation and coordination of technical translations of all relevant documents (e.g. trial protocol, “investigator’s brochure”, information brochures, “informed consent form”, booklets for participants, “information booklets”, etc.
- Translations of study results and adverse event notifications from the respective investigators, taking into account specialist terminology (MedDRA)
- Coordination of the layout of trial “teasers” in a common graphic format (e.g. Adobe InDesign, FrameMaker, etc.)
- Communication with trial sites and branches about all texts until they are released.
- Support for the submission of your texts to the respective ethics committees in the countries where the trial will take place and, if necessary, coordination of the revisions in accordance with the feedback
As part of our pharmacovigilance services, we also offer translations of adverse event notifications within the shortest time frame. In order to ensure that these translations are reliable, we offer the possibility for them to be integrated into your workflow in a coordinated process.
If you have any questions about our services with respect to clinical trials, you can discuss this with our experts at any time. We look forward to your call.