Clinical Trial Translations

TransCom has developed unique clinical trials translation methodologies and processes to maintain the accuracy and validity of clinical trial related documents, and successfully resolve linguistic, cultural and regulatory differences. All clinical trial translations undergo multi-phase and comprehensive quality assurance procedures to achieve the best possible end product.

TransCom works closely with its clients in order to create tailor-made standard operating procedures which answer the QA needs required by each client and study sponsor. These processes can include a bi-lingual verification process, a back-translation and verification process, or any other process suggested by our clients. All translation services and QA are provided at competitive prices and the shortest timelines.

TransCom’s translators, all of whom have background in medicine or the life sciences, are uniquely trained to keep the document’s target audience (participants, ethics committees, investigators, etc) in mind when performing the translation. This assures that all participants in the clinical trial receive clear, understandable and accurate documents, and that the study is performed as professionally and ethically as possible.

TransCom’s regulatory documents department is ISO 9001 certified, and has successfully passed several external audits by major global CROs.

Why should I translate at TransCom? Learn from our clients’ experience.

TransCom regularly translates:

  • Patient Informed Consent Form (ICF)
  • Patient Information Sheet (PIS)
  • Protocol Synopsis/Summary
  • Ethic Committee’s Approval
  • Patient Questionnaires
  • Patient Diaries
  • CRFs
  • EC/IRB Correspondence
  • Investigator’s Brochure
  • Study Contracts
  • Patient Files
  • Lab Reports
  • Hospital Discharge Summaries
  • SAE Reports
  • Clinical Trial Reports
  • Safety Reports
  • CVs
  • Covering Letter Application Form
  • EC List of Members
  • EC’s GCP Declaration
  • IMP Dossier
  • SmPc Protocol
  • Active Trials Outline
  • Letter of Authorization
  • Manufacturer’s Authorization
  • Importer’s Authorization
  • QP Declaration of GMP
  • Example of Label
  • TSE Information
  • Declaration of the GMP Status
  • Manuals
  • Product Labels
  • Scientific Papers

View a list of our clients.