Global Pharmacovigilance

In this global multicultural environment, not all service providers are capable of managing and delivering reliable translations. At Arriello we are in the best position to offer both quality and reliability; two essential elements to avoid unnecessary costs or poor translations, which could affect sales during the marketing of your products.

Our services are provided in accordance with the relevant international standards:

  • EN-15038 European quality standard for translation
  • ISPOR guideline
  • The International Conference on Harmonization of Technical Requirements for Registrations of Pharmaceuticals for Human Use (ICH)
  • Declaration of Helsinki

This assures us that we provide a range of high quality and reliable services.

EN 15038 standard

This is a specific standard for translation services which covers all aspects involved in providing these services as well the core translation process, in order to ensure the quality of deliverables.

It also establishes requirements for the translation service provider with regard to human and technical resources, project management, contractual framework, etc.

Key elements to the translation process

  1. Quality is only guaranteed when the translation is revised by a person other than the translator.
  2. The professional skills of each agent in the translation process, namely the translators, revisers, editors and proofreaders.

How we measure our translators’ performance

Our evaluators/proof-readers who conduct the Quality Assurance (QA) are based in the country where the translation is being sought.

All proof-readers must complete a Quality report. This tool allows us to track and monitor trends in the quality of our translations in all languages, as well as helping us to improve the quality of all these languages.

Quality Control Methods

We have implemented various Quality Control methods depending on the needs identified or agreed upon with the client:

  • One-step revision of translations
  • Two-step revision of translations – The patient is end-user
  • Translation process for the European Medicines Agency (EMA) regulations

Business Cases

  • Case Study detail

    Local Pharmacovigilance Management

    Global Pharma Company, United States
  • Case Study detail

    Full outsourced EU Pharmacovigilance system

    Leading Generic company, North America

Contact Us

If you want to dicuss how you can be safe in our hands, please contact us for a consultation.

Telephone: +353 125 44033
Email: marketing@arriello.com

Contact Form