informed consent FORMS

CROs conduct clinical trials worldwide on behalf of pharmaceutical and medical companies.

While this increases the patient pool and the opportunity to get the necessary data from diverse ethnic backgrounds, it also necessitates ensuring accuracy in communication.

A large portion of the interaction in the clinical trial process takes place between clinicians and patients. This means that patient-facing materials must be translated to match the patients’ reading levels and to facilitate understanding of potentially complex medical issues.

Before a patient can be enrolled in a clinical trial, he or she must be aware of why the study is being done, what it entails, what the risks and potential benefits are, and what legal or insurance issues come into play. Informed consent forms are therefore very sensitive documents that need to be translated with utmost care and diligence. At KONTEKST, we understand that and are fully committed to delivering the best translation service in this respect, including additional services such as double revision process, back translation, and reconciliation.

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