Patient Diaries Translation Services
We specialize in patient diaries translations to help sponsors succeed in the global clinical trials market
With a growing number of clinical trials being conducted overseas , patient diaries require precise translation in order to ensure the accurate documentation of the experiences of diverse, multilingual patient groups. 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, patients are directed to record information on adverse events, potential side effects and symptoms, including the specific times when the medication in question was taken. A successful clinical trial enables patients to accurately and efficiently document qualitative data on their experience to ensure a safe, patient-centric, 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 250+ languages.
Clinical Outcome Assessment (COA) Translation Services
In addition to patient diary translation services, 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 outcomes (PerfOs), and observer reported outcomes (ObsROs). Clinical outcome assessment translations help life science companies provide transparency to regulators, drug developers, and patients, and are required by most regulatory bodies including the FDA and EMA. In addition, the information provided in COA translations helps to inform sponsors, physicians, and regulatory bodies of potential ways to improve patient care and make informed healthcare decisions.
Learn more about our full range of clinical outcome assessment (COA) translation services.
Mobile Medical App Translation Solutions: Electronic Patient Diaries
As the medical devices and medical software markets continue to grow internatinally, mobile medical application translations enable companies to expand their operations globally and reach new markets. Mobile applications are becoming an increasingly central feature in many industries, and the use of this technology in the medical field and in clinical trials is opening new and innovative opportunities to enhance patient-centric care. With a global team of in-country linguists and regulatory specialists, we can help ensure regulatory submission compliance while providing the highest-quality translation and localization solutions, helping life science companies gain market access with confidence.
Learn more about our mobile medical app translation solutions.
End-to-End Clinical Trial Translation Services
With a growing number of clinical trials being conducted overseas, accurate translations are essential for conducting any clinical trial and meeting international regulatory requirements. These clinical trials require 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, including documents for remote monitoring in clinical trials. We have proven experience translating essential clinical trial content, including:
Clinical Trial Protocol Translation Services
Clinical trial protocol translations are essential for ensuring that all aspects of a clinical trial are compliant with international regulations, and that the objectives and conduct 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, including patient diaries. 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 materials 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
Learn more about our clinical trial protocol translation services.
Real-World Data Translation Services
Real-world data translations are critical to enabling companies and researchers to understand and address patient needs in the modern world. Real-world data (RWD) is medical and health knowledge collected outside of randomized clinical trials or the laboratory, such as data from electronic health records and disease registries, as well as wearable health technologies and census data – but can also include patient-reported outcomes, like patient diaries, in clinical trials. These patient-centric metrics help pharmaceutical, medical device, and other industry groups to best serve diverse patients across languages. With a global network of over 10,000 linguists and medical subject matter experts, CSOFT Health Sciences is experienced in working with life science companies involved in RWD collection and application.
Learn more about our real-world data translation services.
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.
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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.