Translation & Validation

TCA provides comprehensive translation and linguistic validation services for trials that have been conducted internally or have been contractually managed externally, as well as documentation for regulatory bodies. Our broad clinical study experience allows us to provide quality translation, verification and back translation resulting in accurate and professional renditions of the following documents into Hebrew, English, Arabic and Russian.
  • Clinical Study Protocols and Case Report Forms (CRF, eCRF)
  • Clinical packaging and labeling
  • Instructions for use
  • Local ethics committee and MoH submissions and approvals
  • Summaries of Product Characteristics (SmPC)
  • Patient Information Leaflets (PIL)
  • Patient Informed Consent Forms (ICF)
  • Patient Questionnaires
  • Subject (patient) diaries (paper cards, dial-in phone reports and electronic formats)
  • Patient-Reported Outcomes (PRO)