What Are Lay Summaries?
With evolving regulations and an increasing focus on transparency, many organizations are working on developing Plain Language Summaries (PLS), which makes lay summaries translations an essential medical communications asset for stakeholders conducting clinical trials. Sponsors are now required to report clinical trial results in the EU, and as the world deals with the COVID-19 and other pandemics, transparency and the need to simplify trial outcomes into simple, comprehensible language has become even more important.
Well-crafted lay summaries build trust with the patient population and increase public interest as well. Communicating complex scientific information in simple lay language while ensuring compliance requires expertise and unique skill sets. Documents need to be non-promotional and factual, and need to incorporate principles of health literacy, numeracy, and cultural literacy. The authoring of lay summaries also requires a deep understanding of regulatory requirements so as to ensure compliance. Linguistic skills are required to be able to adapt content and style to populations from different cultures. Visual imagery is another critical component for a lay summary, as a picture may often communicate more than words alone.
In Europe, lay summaries also need to be translated into all European languages in the countries where the trial is being conducted. The use of native, in-country linguist 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 that 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 the regulatory requirements and language needs of patients demands high volumes of multilingual clinical trial documentation. With lay summaries being just of one of the many essential documents for patient communications, trial sponsors are responsible for providing translations for documents ranging 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 localizations solutions, including:
Through our innovative cloud-based technology, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time.
Professional, high-quality localization of a health service or medical product is critical for medical translation solutions entering global markets. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance to ensure that any project that is translated meets quality standards in a timely manner that is also cost effective. Our advanced translation technology management system allows for translation projects to remain in one centralized location, updated in real time, to ensure that every step of the way, CSOFT has you covered. Additionally, we are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, and our operations leverage best practices of ISO 27001 to ensure our customized solutions meet global regulatory requirements.
Learn more about our quality assurance process.
As an ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified company, with operations leveraging best practices of ISO 27001, CSOFT’s translation process includes in-country reviewers, utilizing either new or established style guides, and subject matter expert (SME) linguists with a minimum of 7 years of experience. With over 20 years of industry experience, we have developed mature processes for translation, editing, proofreading (TEP), as well as project management.
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