Communications solutions for improving patient trust and growing public interest through the highest quality lay summaries translations.
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:
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 a minimum of 7 years’ experience and work with in-country reviewers and project style guides to meet industry standards. And 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. Every step of the way, CSOFT has you covered.
Learn more about our quality assurance process.
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 best practices of ISO 27001, and are designed to keep everything from source data to translations protected. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be certain that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.