Last year, EVS Translations‘ pharmaceutical client ran two clinical trials to test and develop new products for patients suffering from a major neurological disease. Documentation included data sets from lab testing and other clinical settings, as well as patient questionnaires and summaries from field tests.
Clinical trials are very much intertwined with regulatory compliance. Translation work can be a mix of data-driven texts, complex laboratory jargon or compliance documentation relating to drug registration. Workflows often incorporate in-market reviewers and must account for varying market-specific requirements related to labelling (including the medical codes that are displayed on packaging).
The translation and localisation work supports the process of bringing these new products to market, which enables patients all over the world to access better treatments.
Total word count:
500,000+ (project ongoing) from English into most EU languages, including German, Italian, Spanish and French.
Data protection and clinical trial translations
Throughout the duration of this project, the team at EVS Translations had access to highly confidential data and information. Consequently, all measures and infrastructure relating to data protection were scrutinised by the procurement management team during the supplier selection process. Translation companies must provide evidence of a robust infrastructure (including dedicated personnel), while also providing considerable detail about all individual measures at each stage:
– Data transfer
– Data storage
– Controlled access
This is no easy feat and data protection can be a major stumbling block for smaller providers. Once documents are exchanged, it can be incredibly difficult to manage the flow of information and to ensure that all parties in the process chain are handling it in a secure way.
Information security management for translation services
The IT team at EVS Translation works in line with the current industry standards for information security management. What’s more, on a project-by-project basis, we can help clients to add extra ‘layers’ to security protocols, depending on any specific client preferences. For example:
– A VPN (Virtual Private Network) connection to your firm’s network is possible so documents never enter the provider’s network.
– In addition to cryptography in transport, encrypted storage is also an available option.
– Access restrictions can be clearly defined and should follow the ‘need to know‘ principle.
– Personal data can also be anonymised / pseudonymised in accordance with the GDPR.
This is worth keeping in mind, since not all translation projects for pharmaceutical companies will require the levels of security that are necessary for clinical trial translation.
It was a privilege for EVS Translations to be selected by the Clinical Trials, Research and Development procurement team of this major pharmaceutical company to manage the translation and localisation process for the two clinical trials.
If your company requires translation and localisation support for clinical trials, contact our team today. They can discuss objectives with your team to develop workflows that meet the specific needs of your project, including those relating to data protection.
Why not read our other case study, which looks at quality management for pharmaceutical translations?
EVS Translations UK Ltd.
+44 (0)115 964 4288
EVS Translations USA Inc.
EVS Translations GmbH
+49 69/82 97 99-99
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