As clinical studies continue to expand worldwide, trial close-out monitoring report translations have become essential in ensuring all activities are accurately reported at the conclusion of the trial. To access foreign markets, documents such as study close-out reports and clinical trials agreements are important to translate accurately both to meet regulatory requirements and for future clinical trial inspections.
To support, CSOFT Health Sciences provides customized translation and localization solutions that we deliver worldwide through our global team of 10,000+ in-country linguists and subject matter experts. We provide translations for a full range of content, documents, and materials for medical professionals and researchers in global clinical trials, including:
- Result Submission Translations
- Study Close-out Report Translations
- Clinical Trials Agreement Translations
CSOFT’s translation and interpreting support in over 250 languages enables growing healthcare and research organizations deliver trial close-out monitoring report solutions across language barriers.
Clinical Trial Protocol Translations
When reporting all trial activities, clinical trial protocol translations are vital for ensuring that the standard operating procedures and the scientific protocols of a trial are completed and met. Clinical trial protocols play an important role by establishing a clear and descriptive document that can be followed and assessed by a regulatory body while remaining in compliance with Good Clinical Practice (GCP) guidance. To support companies conducting clinical trials on a global scale, CSOFT Health Sciences provides translations for required protocol features, including IRB correspondence translations, Investigator’s Brochures (IBs) translations, and Informed Consent Form (ICF) translations.
Learn more about our clinical trial protocol translations.
Adverse Event Reporting Translations
Adverse event reporting translations are important when documenting clinical activities in trial close-out monitoring reports. During clinical trials, adverse events (AE), serious adverse events (SAE), and adverse drug reactions (ADRs) are expected to be reported to the regulating agency within specific timelines, which can be as short as 7 days as outlined under FDA regulations. Clinical documentation for all SAEs, ADRS, and AEs is an integral process for ensuring the safety of trial subjects and proving the efficacy of new medical devices and pharmaceutical products. With an increasing number of clinical trials being conducted internationally, the ability to provide multilingual adverse event reports and documents is required by many global regulators and is essential for avoiding potentially life-threatening situations.
Learn more about our adverse event reporting 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 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.
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 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.