Study Startup Translations

We combine advanced translation technology with our expert linguists for the highest-quality Study Startup Translations for life science companies expanding globally

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Study Start-up 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 subjects, which is why Study Startup Translations are such an important aspect of the process. CSOFT’s global network of translators offers linguistic and in-field experience to help the world’s leading companies confidently conduct Study Startups.Also called SSU, 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, site training and ends with the site initiation visits.

The study start-up process sets a study up for ultimate success or failure, and there are key elements which 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, creation and utilization of 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’s global network of translators offers linguistic and in-field experience to help the world’s leading companies confidently conduct Study Startups.

Our Tools and Methodologies

CSOFT Health Sciences brings almost two decades of translation expertise to delivering quality multilingual documentation for the life sciences. Perfecting our translation best practices, our cutting-edge cloud-based language technology as well as our linguistic validation process, ensures the highest quality translation services, including.

ISO-certified Academic Translations

Data Security

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.

Quality Assurance

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.

High Quality Academic Translations

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