Ingenuiti Clinical Portal Streamlines Global Clinical Trial Translations
Industry: Medical
Services: Web Portal Localizaiton
Company region: Worldwide
Background
Ingenuiti’s client, a leading multinational corporation in the Life Sciences industry, regularly conducts clinical trials at multiple sites across the globe. This presents unique translation and localization challenges, particularly for medical safety reports generated when adverse events occur. These reports require rapid translation to enable clinical safety coordinators to review incidents and determine if submissions to regulatory authorities are necessary.
Key Challenges
The client faced several challenges in managing the translation of medical safety reports:
- Urgency: Medical safety reports require very fast translation to ensure timely review and potential regulatory submissions.
- Uneditable Formats: Reports are often transferred in uneditable formats, hindering the use of translation technologies that could expedite the process.
- Variable Language Combinations: The language combinations for each study are unpredictable, depending on the location of the adverse event.
- Data Security: Strict adherence to HIPAA and European Data Protection regulations is essential to protect patient data.
Solution
Ingenuiti collaborated with the client to develop a comprehensive solution:
- Clinical Portal: A custom online clinical portal was created to provide a standardized framework for managing safety report translations, prioritizing regulatory compliance, efficiency, and audit trails.
- Global Project Submissions: The portal enabled 24/7 global project submissions through secure file transfer, ensuring accessibility and data security.
- User Rights and Permissions: Strict user rights and permission levels governed access and activity within the portal, safeguarding sensitive information.
- Controlled Template: A controlled template for translated documents ensured consistency and cost savings.
- Project Notes Log: A project notes log reduced non-essential emails, created an audit trail, and archived all project communication.
- Financial Tools: Integrated financial tools streamlined quote approvals, invoice management, and financial record keeping.
- Linguist Recruitment and Training: A recruitment checklist ensured linguists possessed appropriate knowledge and subject matter expertise, and a custom training program prepared linguists for each study’s specific requirements.
Results
The implementation of the Clinical Portal and associated processes yielded significant benefits:
- Streamlined Processes: The client streamlined its global processing of medical safety reports, improving compliance, efficiency, and organization.
- Enhanced Translation Quality: Pre-qualified and study-specific trained linguists ensured high-quality translations.
- Faster Turnaround Times: Pre-defined financial thresholds and online quote approvals expedited project completion.
- Compliance and Audits: The portal and processes demonstrated compliance with Good Clinical Practice, industry data security standards, and the client’s Quality Management System.
- Key Performance Indicators: Over an eight-year period, 100% of safety reports were submitted through the portal, 96% were delivered on time with a 3-5 day turnaround, and 100% of linguists received study-specific training.
Conclusion
Ingenuiti’s Clinical Portal provided a robust and tailored solution for managing the complexities of clinical trial translations. By addressing the challenges of urgency, diverse formats, variable language needs, and data security, the portal streamlined workflows, improved translation quality, and ensured compliance with industry standards. The successful partnership with the Life Sciences client highlights the effectiveness of customized solutions in optimizing clinical trial processes and facilitating global collaboration.
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