Study Startup Translations
We combine advanced translation technology with our global team of expert linguists for the highest-quality study startup translations for life science companies expanding globally
Study start-up, also called site start-up or SSU, refers to everything that must take place from the first point of contact with the sponsor to the moment that the study team is ready to screen and enroll research subjects, which is why study startup translations are such an important aspect of the global clinical trials process. Study start-up encompasses all of the means required to initiate a study, generating an exceptionally intricate and well-recognized bottleneck with functions performed by numerous individuals in different locations at the sponsor, Contract Research Organization (CRO), and site management levels – every one of which needs to share and communicate data. Clinical trials that get off to a good start are more likely to be successful trials. The study start-up phase is where this occurs and incorporates activities such as investigator selection, regulatory and ethics submissions, and site training. It then ends with the site initiation visits, which marks the practical start of the study.
The study start-up process sets a study up for ultimate success or failure, and there are key elements that can enable the conduct of the study to be more efficient and effective. A feasibility assessment is the best practice for all clinical research sites to fully evaluate the desirability and feasibility of new studies. Other best practices include establishing a communication plan, dissecting the protocol collectively, creating and utilizing study start-up tools and checklists, and techniques to assess any potential issues with protocol adherence. With global resources and medical translation services in over 250 languages, CSOFT Health Sciences’ global network of translators offers the linguistic and in-field experience to help the world’s leading pharmaceutical, medical device, and CRO companies confidently conduct study start-ups.
Clinical Trial Agreement Translations
Clinical trial agreement translations are essential for sponsors to ensure regulatory compliance at international clinical study sites. A clinical trial agreement (CTA) is a legally binding contract used to define sponsor, site, and researcher responsibilities before a clinical trial commences and must account for project goals, financial agreements, patient safety and monitoring, publication, and intellectual property (IP) terms, and more. As industry sponsors increasingly include diverse and multilingual study sites in their clinical trials, CSOFT Health Sciences provides expert CTA translations to help sponsors prioritize patient-centricity and meet clinical trial endpoints efficiently.
Learn more about our clinical trial agreement translations.
Other Medical Translation Services
Many other medical translation services are essential to ensure that a study is feasible, including recruiting a sponsor for the study and selecting study sites. In addition, recruiting patients and creating and completing all the necessary regulatory documents are crucial in implementing a successful study start-up process to innovate health solutions in an efficient manner. With a global team of 10,000+ in-country linguists and subject matter experts, our expertise in medical translation can help you meet study endpoints. Some of the worldwide medical translation and localization services that CSOFT Health Sciences offers include:
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.
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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.