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Translation and Linguistic Validation Services to Support Global Clinical Trials

Language and translation play an increasingly important role in clinical trials. The percentage of clinical trials that get conducted internationally is on the increase.
Translation of clinical trial materials has therefore become an indispensable component of many research projects, whether conducted internally or outsourced to external contract research organizations.

Translations are already recognized as key steps throughout the clinical trial processes, including pre-clinical studies and the individual phases of clinical trials, as well as regulatory submission, manufacturing, marketing and post-marketing surveillance/pharmacovigilance.

As a fully EN ISO 9001:2008 (CSN ISO 9001:2009) certified provider, Moravia's Life Sciences Practice delivers translation and linguistic validation services to many global Life Sciences companies and CROs, for a broad range of materials, including:

  • Clinical Study Protocols and Case Report Forms (CRF, eCRF)
  • Investigator's Brochures
  • Packaging and Labeling
  • Summaries of Product Characteristics (SmPC)
  • Patient Information Leaflets (PIL)
  • Patient Informed Consent Forms (ICF)
  • Patient Questionnaires
  • Patient Diaries, including eDiaries
  • Patient-Reported Outcomes (PRO), including ePRO

Quality Matters

The overall costs of translating may be a very small fraction of the total costs of clinical trials or the overall drug development process, but the costs of incorrect translations are high and the associated risks very real.

Using professional and qualified translation resources is critical, and will accelerate the conducting of clinical trials overseas as well as minimize any risks from inaccurate translations or mis-translations.

At Moravia, we apply our proven quality assurance processes to ensure that translated clinical trial materials provide an accurate, unambiguous and consistent meaning of the original materials, regardless of the source or target languages or their format.

Our robust ISO-driven QA processes are developed to account for the many specific scenarios and individual requirements of our life sciences client organizations. These include:

One-Step Review Translation Methodology

Typically used for non-patient facing materials, this scenario includes a fully qualified/ certified clinical translator utilized for the initial translation into the target language, followed by a complete review of the translated document, where the check is focused on quality, accuracy of the translation, including spelling and grammar.

Two-Step Review Translation Methodology

Typically used for patient facing materials such as Informed Consent Forms, questionnaires or diaries, this scenario includes the process above complemented by another review/reviews focused on subject-matter, cultural and patient facing technical language suitability of the translation for the specific target country market.

Back Translation Verification Methodology

This scenario includes the processes above followed by translation of the translated content back into the source language, a separate review comparing the original source document to the back translated document for accuracy and completeness followed by updating the final translation if required.

Instrument Translation Methodology (PRO)

This specific scenario starts with multiple forward translations (typically two), followed by review and reconciliation, 100% back translation, comparative review, updated translation, cognitive debriefing (pilot testing) and finally post-production with certified delivery.

Regardless of the specific scenario used, Moravia delivers certified translations, with the delivery including a translation certificate that provides translator codes or information on individual translators used for each clinical document.

Linguistic Validation Services

Moravia offers Linguistic Validation services for Patient-Reported Outcomes in accordance with the guidelines developed and provided by the FDA and ISPOR, followed by a complete report. Learn more.

The Right Resources at Your Disposal

To achieve high-quality translations, Moravia uses a network of in-country language experts with teams qualified based on subject matter expertise. With the diversity of the therapeutic areas in the Life Sciences sector, it is essential to assign suitable language experts.

Moravia maintains a rigorous process for qualifying, training and developing our native in-country Life Sciences resources. Our demanding qualification process ensures that linguists:

  • Pass a rigorous screening and testing process
  • Have extensive experience translating life-science texts
  • Receive continuous performance feedback

Global Coverage

The choice of specific regions or countries for conducting clinical trials depends on many criteria including the location of corporate global facilities, costs, regulations and future product launches. In addition to the "traditional" locations such as Europe, emerging market regions are increasingly becoming the location of choice as they offer significant market potential without compromising the quality of the trials.

Life Sciences companies and CROs have already tapped into the potential offered by India, Central and Eastern Europe, or Russia. Latin America and China are now also gaining in popularity.

Moravia delivers translation services into over 120 languages, and we have a special expertise in providing solutions for emerging languages. This means you can single-source the complete translation component of your clinical trials regardless of the countries and languages/cultures involved.

Proven Capabilities

Time is of the essence in clinical trials, which are driven by multiple deadlines and cut-off dates. There are significant costs associated with each day clinical trials are conducted. Any delays in the process which would push out the ultimate approval date, lead to extra costs and lost revenues.

That's why it is important to work with a translation services provider that has the expertise, the capacity and the flexibility to ensure that the translation component of your projects is executed on time, on budget, and meets the critical quality criteria.

To learn more about our solutions for global clinical trials, please complete the Request for Information form and we will get back to you shortly, or see other options for contacting us.