Preclinical research and Clinical trials Preclinical research and Clinical trials

Clinical trials that develop either to test the efficacy, safety and quality of new medicines, or to compare existing treatments and determine which is more or less beneficial, should be ruled by a protocol describing the plan that the study will follow. The structure and content of any clinical trial research protocol conforms to a law-defined model that necessarily includes a series of data, such as the experimental drug, the main objective, the criteria for inclusion and exclusion of participants, among others.   

While being a scientific document, it is intended for very diverse readers, from experts to much less specialized people. For these reasons, if any translation should be clear and accurate, in the field of clinical trial protocols these requirements are even more relevant since the slightest error can have serious consequences and could even endanger the lives of people undergoing the study. 

From Lexic, we offer our clients a highly qualified team of linguists who, in addition to having extensive knowledge of the source and target languages, possess a medical and scientific background. Thus, they can carry out accurate translations because they master the terminology and particular features of the clinical trials language. 

We can also support the industry in the language validation processes that are performed to ensure that the data obtained is consistent regardless of the language in which it was generated or read, and that the clinical results are conceptually equivalent in the multiple languages and cultures of the trial. To do this, our team of medical writers can perform back translation, reconciliation, cognitive reporting and harmonization of responses from Patient-Reported Outcomes (PROs) questionnaires.  

CLINICAL AND PRECLINICAL DOCUMENTATION

  • Clinical trial protocols
  • Informed Consent Forms (ICFs)
  • Case Report Form (CRF)
  • Physician-Reported Outcomes (PhROs)
  • Patient-Reported Outcomes (PROs)
  • Observer-reported outcomes (ObsROs)
  • Quality of Life (QoL) Measures
  • Clinical Outcomes Assessments (COA)
  • Patient Diaries
  • Prospects, SmPC and Product Manuals
  • Pharmacological Studies
  • Ethics Committee approval
  • Scientific articles for medical journals and congresses
  • Regulatory Documents
  • Patents
  • Patient Recruitment Materials
  • Clinical Investigation Plan (CIP)
  • Patient Information Leaflets (PIL)
  • Investigator Brochures
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