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Lay Summaries

Communication solutions for improving patient trust and growing public interest through the highest quality lay summaries translations

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What Are Lay Summaries?

Lay summaries communicate complex scientific information in simplified language while ensuring compliance with regulations. With an increasing focus on transparency, many organizations are working on developing Plain Language Summaries (PLS), which makes lay summaries translation an essential medical communication asset for stakeholders conducting clinical trials or research studies.

Documents must be non-promotional and factual and incorporate health literacy, numeracy, and cultural literacy principles. Linguistic skills are needed to adapt content and style to populations from different cultures appropriately, and visual imagery is a critical component, as a picture can communicate more than words alone.

In Europe, where sponsors are now required to report clinical trial results, lay summaries must be translated into all languages spoken across the countries participating in the trial. Using native, in-country linguists ensures the effective localization of content, addressing cultural nuances and sensitivities

CSOFT Health Sciences offers:

  • Experts that can contribute to PLS Strategy
  • Experts that can help with the development of templates and SOPs
  • Writers with experience in authoring Lay Summaries
  • Graphic designers (to create the visual imagery)
  • Native, in-country linguists who can translate lay summaries into over 250 languages
  • Reviewers – a local, non-scientific panel that can ensure that the content has been localized effectively
  • Creative content developers for the development and review of other patient-centric material

Clinical Trial Translations

With increasing numbers of sponsors conducting clinical trials in overseas markets and across borders, meeting regulatory standards and the language needs of patients requires high volumes of multilingual clinical trial documentation. With lay summaries being just one of the many essential documents for patient communications, trial sponsors are responsible for translating documents from Instructions For Use (IFU) to medication and device labels and Informed Consent Forms (ICFs). With a global network of linguists and subject matter experts, CSOFT Health Sciences provides end-to-end clinical trial localization solutions, including:

Learn more about our clinical trial translations.

Quality Assurance

CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have at least seven years of experience and work with in-country reviewers and project style guides to meet industry standards.  CSOFT offers an online translation management ecosystem for one central location to leverage real-time translation memory and terminology management through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.

Learn more about our quality assurance process.

Data Security

With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage the best practices of ISO 27001. They are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.

Learn more about how CSOFT prioritizes data security.


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