With a growing percentage of clinical trials being conducted in overseas markets, patient diaries translations are essential for ensuring that patients can accurately document their experience in any language. Patient diaries are an important assessment tool for gathering patient reported outcomes (PROs) and measuring treatment compliance throughout a clinical trial. In a patient diary, the patients are typically tasked with recording information on adverse events, potential symptoms, and the specific times when medication was taken. Any successful clinical trial requires patients to accurately and efficiently document qualitative data on their experience to ensure a safe and meaningful outcome. To help sponsors conduct clinical trials in any global market, CSOFT Health Sciences provides consistent, cost-effective, and timely translations for patient diaries and electronic patient diaries.
In addition to patient diaries translations, our network of linguists and subject matter experts have experience with all types of clinical outcome assessment (COA) translations, including patient reported outcomes (PROs), clinician reported outcomes (ClinROs), performance reported outcome (PerfOs), and observer reported outcomes (ObsROs).
Learn more about our full range of clinical outcome assessment (COA) translations.
End-to-End Clinical Trial Translations
With a growing number of clinical trials being conducted overseas, accurate translations are essential for conducting any clinical trial and meeting international regulatory requirements. Clinical trials include a wide range of documents to bring new drugs and therapies to market and in many parts of the world, accurate and timely translations for these documents are necessary to expedite this process. To help sponsors and contract research organizations (CROs) safely and efficiently conduct clinical trials in global markets, CSOFT Health sciences specializes in translations for all types of clinical trial documents and documents for remote clinical trials. We have proven experience translating essential clinical trial content, including:
Clinical Trial Protocol Translations
Clinical trial protocol translations are essential for ensuring that all aspects of a clinical trial are compliant with international regulations and that the objectives of the trial remain consistent, regardless of where the trial is being conducted. Clinical trial protocols contain crucial documents that aim to describe the objective, study design, safety measures, organization, and other important aspects of how the trial will be conducted. Clinical trial protocols also lay the groundwork for successfully replicating the trial in the future, meaning that documents like clinical outcome assessments (COAs) and patient recruitment material must be included. As the global clinical trials industry continues to reach new markets, high-quality and accurate translations for protocol documents are more important than ever. To help ensure a safe and successful clinical trial, CSOFT Health Sciences’ global network of linguists and subject matter experts specialize in protocol translations across 250+ languages.
Learn more about our clinical trial protocol translations.
CSOFT has meticulously documented and fully traceable information security policies, checklists, and quality records. We understand the importance of security to our clients, which is why we take the upmost care in protecting patients’ confidentiality, as well as businesses’ data. All our data and security processes are certified with ISO 13485:2016, ISO 9001:2015, and ISO 17100:2015, and leverage best practices from ISO 27001.
Learn more about how CSOFT protects companies’ data.
High-quality translation is extremely important in the life sciences, and inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance specific to the life sciences, which includes linguistic validation, to ensure that any project meets quality standards in a timely and cost effective manner. To do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts and advanced language technology. In addition, we have perfected our localization best practices through back translation and terminology management to help you reach patients globally, in over 250 languages. To further ensure the highest-quality technical translation solutions, CSOFT’s proven expertise is backed by our ISO 17100:2015,ISO 9001:2015, and ISO 13485:2016 certified quality management system.
Learn more about our quality assurance process.