Regulatory approval guarantee

Novalins is a clinical research translation specialist dedicated to deliver the highest standards in linguistic products to clients worldwide, while always being on-time and within budget.

Our years of experience in the clinical trials field enables us to provide industry-standard expertise and to adapt our processes according to the specific needs of each document at every stage of the product development and registration process:

  • Preclinical studies;
  • Phases 0 to IV;
  • Surveys & Drug testing;
  • Dossiers for regulatory approval.

In addition to clinical research translations, Novalins also provides additional language solutions such as the translation and linguistic validation of Patient Reported Outcomes (PRO) instruments, comparative reviews and clinical trial back-translation.

Experts

Novalins has a strong and growing team of medical translators and editors who specialise in clinical translation in 120 different languages. All our experts meet a minimum criteria:

  • Native speakers of the target language with perfect command of the source language
  • Extensive linguistic, scientific and medical background (M.A., M.S., PhD, MD)
  • Certified medical translators by recognised bodies
  • Clinical trial & research subject-matter-experts

Novalins offers our clients full transparency on the experience and qualifications of the medical translators and editors who work on their projects.

Documents

Novalins offers comprehensive clinical translation and localisation services that cover all documents that are produced at all stages of clinical trials. The most frequently translated documents include:

  • Patient Information Sheet (PIS)
  • Informed Consent Forms (ICFs)
  • Case Report Forms (CRFs)
  • Patient Reported Outcomes (PROs)
  • Patient Questionnaires
  • Study Protocols
  • Patient Diaries
  • Medical Records
  • Investigator’s Brochures

Services

In addition to clinical translation and localisation services, Novalins also offers the following services:

  • QA/QC solutions: Back translation, Source & target text editing by SMEs
  • Linguistic validation of PROs
  • Medical writing
  • Medical translation
  • Medical transcription
  • Data entry (CRFs)
  • Linguistic consultancy
  • Sworn – Certified translation
  • Translation memory management
  • Terminology database management
  • Page formatting (DTP) and layout preparation

Please contact us for the complete list of solutions we offer.

Confidentiality

Novalins understand the sensitivity of clinical trials and research documents and all our medical translators and experts work under binding non-disclosure agreements. We are also open to any additional confidentiality arrangements requested by our clients.

Our clinical trial translations include the following quality steps:

  • 01

    Translation by a senior medical translator, native speaker of the target language with perfect command of the source language and specialization in the subject matter

  • 02

    Proofreading/editing by a second equally qualified translator with subject matter expertise and significant experience with translation for clinical research and clinical trials.

  • 03

    Non-linguistic accuracy review by an additional reviewer

  • 04

    Final review by a Novalins project manager specialized in medical translation.

  • 05

    We can also issue a Certificate of Accuracy detailing the quality steps taken as well as the qualifications of the translation team that worked on your project.

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