Managing Version Changes in Clinical Trial Documents in Korea

The Challenge: Frequent Updates & Change Management in Clinical Trial Documents

Clinical trial documents undergo regular updates, and accurate version control is essential to ensure translations align with the latest changes. A global CRO faced challenges maintaining accurate translations while ensuring changes were effectively tracked.

Key Issues:

1. Complex Version Management:

2. Frequent updates made it challenging to track changes and ensure accurate translations. Delayed detection of changes increased the risk of translation errors.

3. Difficulties in Change Detection Across Languages:

4. Translators needed to efficiently identify changes in multiple translated versions, leading to delays and increased time demands.

5. Maintaining Consistency Across Versions:

6. Consistency and efficiency in translating changes were critical to avoid discrepancies and ensure timely document submission.

   
   

MediTrans' Solution: Efficient Change Tracking with Advanced Tools

MediTrans implemented a systematic approach using Microsoft Word's "Track Changes" feature to resolve these challenges, enabling real-time tracking, collaborative management, and streamlined workflows.

1. Real-Time Change Tracking Using "Track Changes"

The Track Changes tool allowed MediTrans to monitor all edits in clinical trial documents, making changes transparent and traceable.

• Highlighted Changes:

• Additions, deletions, and modifications were marked, enabling translators and editors to focus only on the updated sections.

• Document Comparison Made Easy:

• The comparison of prior versions with updated changes was simplified, ensuring that translations reflected only the most recent changes.

• Streamlined Collaboration & Review Processes

Using the Track Changes system improved team collaboration and review workflows:

• Focused Work for Translators:

• Translators worked only on newly modified sections, saving time without compromising quality.

• Real-Time Review for Editors:

• Editors could quickly review and validate changes in real-time, improving oversight and translation accuracy.

This collaborative process saved time reduced the likelihood of errors and maintained high-quality translations under tight deadlines.

Results: Effective Version Management & Timely Translation

Through MediTrans' strategic implementation of change tracking and streamlined workflows, the client achieved the following:

✅ Accurate Change Integration:

All updates were tracked and accurately reflected in translated documents in real-time.

✅ Efficient Version Management:

Changes between versions were identified, simplifying the management process and ensuring seamless document updates.

✅ Timely Completion of Translations:

Translators focused only on newly updated content, reducing turnaround times and meeting strict deadlines.

✅ Improved Process Efficiency:

The new workflow saved the client time and resources while maintaining translation quality and consistency.

MediTrans' Technological Approach

By leveraging Track Changes and advanced document management workflows, MediTrans addressed complex version changes effectively:

• Real-time updates and accurate translation alignment ensured that every change was addressed without delays.

• Efficient team collaboration improved review and editing processes, streamlining translation cycles.

MediTrans prioritizes confidentiality by signing an NDA with clients. This case is based on a real example, but the client name and project details have been changed.