Client: Leading manufacturer of implantable medical devices requires localization of clinical study documentation.
Challenge: This clinical translation client required English versions of safety reports, generated worldwide during a large, five-year clinical study, to present to Clinical Events Committee members for review. The process had to allow for global project management, be flexible to accommodate unpredictable timing and source languages and provide an audit trail. The custom portal required validation to FDA standards for the hardware, software and OS.
Solution: To ensure we met this challenge, OmniLingua Worldwide:
- Collaborated with the client to create standard specifications and workflow for all submitted projects, including file naming conventions, duplication confirmation, and redaction of confidential/controlled information
- Customized an online portal to document all project activity and to allow global 24/7 project submission and management, including file transfer, project approvals and change request process management
- Integrated financial aspects of project management into the online portal (i.e., approval of quotes, review and approval of invoices) to reduce nonessential emails and create a central repository for financial records
- Reduced cost by designing a formatting process, based on use of a controlled template, to lock required information and use of source formatting
Result: To support global management of clinical study safety reports, OmniLingua Worldwide was able to establish a controlled localization process while meeting the client’s regulatory, quality and turnaround requirements. Specific results include:
- Online portal achieved client-certified FDA compliance
- System and process 21 CFR Part 11 compliant, protecting patient data
- Operationally exceeded delivery and quality expectations
The word from our client: “This is cutting-edge GDP” (Good Documentation Practice). If you’re interested in reviewing more customer feedback, contact us.