Case report forms (also known as CRFs) are questionnaires commonly used in clinical trials for hypothesis testing and data analysis. CRFs are used by clinical trial sponsors and site personnel to collect patient information that informs the study’s efficacy and safety endpoints such as weight, height, respiration, temperature, blood pressure, pulse, date of visit and any adverse events that the patient may experience during the clinical trial. However, the type of data collected can be changed depending on the specific disease being studied and the study protocol. After the data on the CRF is captured, it is analyzed and sent to the sponsor’s database. After the clinical study is over, the CRF data is further analyzed to see the effectiveness of the drug or medical device, and the results are included in the clinical study report.
Although CRFs are traditionally paper questionnaires, electronic CRFs, or eCRFs, have become increasingly popular due to more rapid database lock, enhanced online discrepancy management, and better data quality. In addition, electronic case report forms offer the advantage of facilitating multicentric clinical studies due to more convenient administration. An eCRF also offers the advantage of being able to handle multiple large studies with similar designs.
As the world becomes increasingly global, more and more life science companies are holding clinical trials, especially Phase III trials, in regions where English is not the primary language. For multilingual clinical trials, CRFs and eCRFs play a key role in documenting clinical data that determines if the drug or medical device performed as expected. In addition, since the information in CRFs is required for AE and SAE reporting by regulatory agencies like the FDA and EMA, accurate translations of CRFs are vitally important to not only avoid wasting money through incorrectly entering data, but also maintaining regulatory compliance for clinical trials and proper safety reporting.
Given the importance of CRFs and eCRF in maintaining regulatory compliance and ensuring clinical trial outcomes, high quality and timely CRF and eCRF translation is vital for life science companies to successfully conduct multilingual clinical trials. With a network of 10,000 global linguists and subject matter experts (SMEs), CSOFT provides timely and accurate CRF and eCRF translations backed by stringent quality assurance, enabling life science companies conducting international multilingual clinical trials.
Clinical Trial Protocol Translations
With an increasing demand in clinical trials globally, clinical trial protocol translations are essential to ensure that the standard operating procedures can be repeated or assessed in the targeted market. Following the protocols of clinical trials can ensure that case report forms are successfully repeated to the same standards, ensuring safety of the trial and integrity of the data collected. With a global team of 10,000+ linguists and subject matter experts, CSOFT Health Sciences can provide timely and precise translations to ensure protocol features are being met.
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Informed Consent Form Translations
Informed consent form translations are crucial to maintain the patient’s safety and legal security for healthcare professionals and businesses in life sciences. Patients must have a full comprehension of regulatory requirements to verify appropriate reporting and analysis of data for health professionals involved in clinical trials. To recruit patients across the globe, CSOFT Health Sciences provides accurate and reliable informed consent form translations in over 250 languages to ensure that medical professionals can recruit patients to participate clinical trials in a safe manner, ensuring the consistency of case report forms.
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Drug Trial Protocol Translations
To gather the suitable information and analysis of data, the drugs utilized in the clinical trial must be safe to use, making drug trial protocol translations critical in maintaining the integrity of data. If the drug protocols aren’t met due to mistranslation, then the data collected may be inaccurate which can lead to a compromised case report form. To sustain high quality of data, CSOFT Health Sciences’ team of 10,000 linguists and subject matter experts can verify the appropriate use of drugs in clinical trials, allowing medical professionals to successfully release a case report form.
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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.
Professional, high-quality localization of a health service or medical product is critical for medical translation solutions entering global markets. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance to ensure that any project that is translated meets quality standards in a timely manner that is also cost effective. Our advanced translation technology management system allows for translation projects to remain in one centralized location, updated in real time, to ensure that every step of the way, CSOFT has you covered. Additionally, we are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, and our operations leverage best practices of ISO 27001 to ensure our customized solutions meet global regulatory requirements.
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As an ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified company, with operations leveraging best practices of ISO 27001, CSOFT’s translation process includes in-country reviewers, utilizing either new or established style guides, and subject matter expert (SME) linguists with a minimum of 7 years of experience. With over 20 years of industry experience, we have developed mature processes for translation, editing, proofreading (TEP), as well as project management.
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