Preparation of Multi-Language Regulatory Documents for Clinical Studies Worldwide

TransCom has developed translation methodologies and processes to assure the accuracy and validity of all types of regulatory documents.  Our clients know that we are absolutely reliable and all of the work we do is consistently of the highest quality.  All clinical trial translations undergo multi-phase procedures and comprehensive quality assurance procedures to achieve the best possible end product. 

TransCom's medical translators undergo a thorough screening process, a long training procedure and periodic inspections, all with the primary objective of observing the fundamental principles of professionalism and uncompromising quality. Most of the translators are physicians (MD) and MA or PhD graduates in chemistry, biology, etc., as required by the particular field of expertise, each translating to his/her own mother tongue. All of TransCom's translators signed a Non Disclosure Agreement.

TransCom's medical translators specialize in translating various types of medical documents, amongst which:

• 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
• A 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
• Etc.

Back Translation
Back-translation is an integral and essential part of the QA process, and is therefore included in many pharmaceutical companies' SOPs. Back translation is conducted in order to monitor the quality and reliability of the translation. TransCom has vast experience is providing back translations and is well-equipped for this service, with a wide range of translators trained and specialized in back translation.

Certificate of Translation & Validation 
Upon completion of the project, translations are forwarded to the client together with a signed and stamped Translation and Validation Certificate. The certificate includes all the necessary information regarding the translated document (names of translators, protocol number, title of document, version no., version date, etc.)

Additional Medical language Services