Process Documentation Translations for Multilingual Clinical Trials
With a growing number of drugs being developed in the pharmaceutical industry, drug development process documentation translations are necessary to adhere to regulatory standards to access markets across the globe. Whether for a pharmaceutical company, clinical research organization (CRO), the U.S. Food and Drug Administration (FDA), or the European Union (EU), process documentation ensures that drugs going through all phases of the development cycle meet regulations as needed to ensure safety and efficacy.
With a global team of 10,000+ in-country linguists and subject matter experts, CSOFT Health Sciences provides high-quality, customized medical translation and localization solutions for a full range of content, documents, and materials for research organizations and companies in the drug development field, including:
- Clinical Trial Protocol Translations
- Informed Consent Form Translations
- Investigator’s Brochure Translations
- Pediatric Study Plan (PSP) Translations
- Pediatric Investigational Plan (PIP) Translations
- Investigational New Drug Application (IND) Translations
- Investigational Medicinal Product Dossier (IMPD) Translations
- Statistical Analysis Plan (SAP) Translations
- Pregnancy Prevention Plan (PPP) Translations
- Development Safety Update Report (DSUR) Translations
- Clinical Safety Report (CSR) Translations
- Risk Evaluation and Mitigation Strategies (REMS) Translations
- Risk Management Plan (RMP) Translations
- Clinical Overview Assessment Translations
From clinical studies to post-market safety monitoring, CSOFT’s medical translation and interpreting support in over 250 languages enables growing healthcare and research organizations to deliver drug development process documentation solutions across borders by bridging language barriers.
Drug Trial Protocol Translations
For any pharmaceutical company documenting the drug development process, drug trial protocol translations are a necessary step for ensuring the safety of trial participants and upholding the integrity of the data that is being collected. Protocols for pharmaceutical products in clinical trials are designed to standardize the study’s objective, design, safety measures, organization, statistical analysis, and other key aspects, to ensure that any replication of the trial can be successful and held to the same standards. To facilitate success in developing new pharmaceutical products while adhering to regulatory standards, CSOFT Health Sciences offers high quality and cost-effective translations for drug trial protocols.
Learn more about our drug trial protocol translations.
Pharmaceutical Product Guidance Translations
When documenting the latter process of drug development, pharmaceutical product guidance translations help companies expand into new markets and remain in compliance with both domestic and international pharmaceutical regulations. Since the global pharmaceuticals industry is heavily regulated, and meeting the safety and documentation requirements for the approval of new products is critical to success in overseas competitive markets, companies must be able to understand and follow the FDA-issued guidance across languages. Leveraging a global team of linguists with over 7 years’ experience and expertise in regulatory and pharmaceutical translations, CSOFT Health Sciences offers high-quality pharmaceutical product guidance translations to help companies and professionals succeed in the global pharmaceutical industry.
Learn more about our pharmaceutical product guidance translations.
Adverse Event Reporting Translations
Adverse event reporting translations are necessary to report in drug development process documentations to successfully bring new products to the market. With an increasing number of clinical trials being conducted internationally, being able to provide multilingual adverse event reports and additional regulatory documents is required by many global regulators, and is essential for handling potentially life-threatening situations with clinical trial participants. With a global network of over 10,000 linguists and subject matter experts, CSOFT Health Sciences offers fast turnaround times to meet your adverse event reporting translation needs across 250+ languages.
Learn more about our adverse event reporting translations.
Clinical Study Report Translations
As new medical treatments continue to expand in global markets, clinical study report translations are required to analyze the methods and outcomes of multilingual clinical studies. As clinical research organizations (CROs) and other life science companies continue to release applications for new medical treatments to access foreign markets, complying with global regulatory standards is needed to ensure credibility. With a global team of in-country linguists and subject matter experts, CSOFT Health Sciences provides high-quality customized medical translation and localization solutions for clinical study reports (CSRs). From outcome analysis to medication evaluations, CSOFT’s medical translation and interpreting support in over 250 languages enables growing healthcare and research organizations to deliver clinical study report solutions across languages.
Learn more about our clinical study report translations.
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 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.
Learn more about our quality assurance process.
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 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.