Solutions for Contract Research Organisations

Contract Research Organisations (CROs) support pharmaceutical, biotechnology, and medical device companies during clinical trials studies across many country and regions.

My extensive 9-year experience in Medical & Pharmaceutical Linguistics, 5-year experience in Medical & Pharmaceutical Marketing Consulting, and deep knowledge or Russian and Belarusian clinical trials industry help Contract Research Organisations meet their goals. Whether it involves translation, interpretation, linguistic validation or localisation services, I can provide the necessary flexibility and capacity to accommodate any specific situation.

Types of Solutions

As a professional Medical Linguist, I offer the following types of linguistics services in English to Russian (Russian to English) and English to Belarusian (Belarusian to English) language pairs and consulting services in English, Russian and Belarusian languages for Contract Research Organisations conducting clinical trials in Russia, Belarus or other Russian-speaking countries as well as in English-speaking communities:

  • Translation
  • Editing & Proofreading
  • Data Synthesis
    • Systematic Literature Reviews
    • Meta-analysis
    • Indirect Treatment Comparison
  • Interpretation
  • PRO (Patient Reported Ouctomes) instruments linguistic validation
  • IT Localisation (software and websites localisation)
  • Marketing Consulting
  • Cultural Consulting
  • Copywriting
  • Scientific Writing

Types of Documents

My translation and editing services in English to Russian (Russian to English) and English to Belarusian (Belarusian to English) language pairs cover all types of documents needed to support every phase of clinical trials, including, but not limited to, the following:

  • Case Report Forms (CFRs), including eCRFs
  • Clinical Trial Reports
  • Informed Consent Forms (ICFs)
  • Investigators Brochures (IBs)
  • Patient Diaries
  • Patient Reported Outcomes (PRO) instruments, including ePRO’s
  • Protocols/study plans
  • Rating Scales
  • Safety reports
  • and more…

Highlights

  • Ultimate accuracy and precision
  • Fast translation and editing turnaround time
  • Adherence to unique terminology requirements (e.g., EN source, QRD templates, MedDRA, EDQM Standard Terms, etc.)
  • Compliance with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines

Whether a Contract Research Organisation conducts a clinical trial in English- or Russian-speaking countries, including Russia and Belarus, I can guarantee highest quality and always timely linguistics and consulting services in English, Russian and Belarusian languages.