During a clinical study, patient safety narratives are a required document for clinical safety reporting and supporting pharmacovigilance activities, which makes patient safety narrative translations essential for ensuring consistent, accurate, and transparent documentation when communicating across languages any and all events related to test drugs and investigational products. As mandated by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E3 guidelines for clinical study reports (CSRs), compliant patient safety narratives are required for all phases of a clinical trial. These could include narratives for SAEs (Serious Adverse Events), deaths, and AESIs (Adverse Events of Special Interest), or those triggering study discontinuation. The narratives summarize specific events during a clinical trial, making high quality translations crucial if clinical studies are conducted with multilingual patients or regulatory guidelines require reporting in multiple languages.
CSOFT Health Sciences leverages a global team of over 10,000 subject matter expert linguists to provide the most accurate and compliant patient safety narratives translations for CROs, pharmaceutical companies, and other life science groups performing clinical trials worldwide.
Clinical Study Report (CSR) Translations
As new medical treatments continue to expand in global markets, clinical study report translations are required to analyze the methods and outcomes of clinical studies. Patient Safety Narratives constitute an essential component of clinical study reports (CSRs) and assist in evaluating the safety profile of the investigational product. Furthermore, patient safety narratives must follow specific style guides and formats in order to be accepted by the US Food and Drug Administration (FDA), Data Safety Monitoring Board (DSMB), or other regulatory authority.
To help trial sponsors and contract research organizations (CROs) adhere to international regulations and document safety reports across different languages, CSOFT Health Sciences’ network of medical writing and experts and subject matter experts provide cost-effective and accurate patient narrative translations, with coverage in over 250 languages.
Learn more about our clinical study report translations.
Medical Writing Translations
For the patient safety narrative to be compliant with ICH E3 standards, the narrative should address various aspects such as the nature, intensity and the outcome of the event, details around the study drug administered, whether it was discontinued, and should narrate how the event evolved, concomitant medications, medical history, post-mortem findings in case of death, and should provide a causality assessment as well.
In addition to having a robust understanding of the therapeutic area and the molecule, as well as key regulations, narrative writing and medical writing requires excellent project management skills, as it requires coordinating with multiple stakeholders to drive alignment on aspects such as data sources, formats, templates, cut offs, whether the narrative will be authored pre- or post- database lock, etc. With proven experience in patient narrative localization, CSOFT Health Sciences also offer translations for all different types of medical writing, including:
Learn more about our full range of medical writing localization solutions.
Expertise in Medical Writing Translations:
What We Bring to the Table
These documents need to be authored in an objective and a scientific manner, while also telling a story that narrates the evolution of the event. CSOFT Health Sciences provides medical writing experts with:
- Rich expertise across diverse therapeutic areas
- Significant experience in authoring patient safety narratives
- Fast turn-around times by leveraging teams across the globe
- Stringent quality processes
- Client-facing project managers in the desired geography
- Translation services to support global submissions
End-to-End Pharmacovigilance Translations
For clinical trials involving new biopharmaceuticals such as medicines and vaccines, accurate pharmacovigilance documentation is necessary for regulatory compliance and ensuring the safety and efficacy of the new therapy before it is brought to market. In order to monitor, detect, and prevent adverse events (AE) relating to a new pharmaceutical product, high volumes of documentation, including individual case study reports (ICSR) and periodic safety update reports (PSUR) must be submitted by pharmaceutical companies or manufacturers. To help bring pharmaceutical products to market overseas and accurately report drug safety complications, CSOFT Health Sciences provides accurate pharmacovigilance translations for essential documents, including:
- ICSR Translations
- PSUR Translations
- DSUR Translations
- PBRER Translations
- Risk Management Plan Translations
Learn more about our end-to-end pharmacovigilance 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.