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For nearly 30 years, the ICH GCP guideline has set the international standard of ethics and quality for conducting clinical trials.  The latest version, ICH GCP E6 (R3), was adopted on 06 Jan 25, an update 9 years in the making.  It contains an entire appendix dedicated to the Trial Master File.  Let’s explore some…

Ensure a Smooth and Compliant Migration with Expert Insights Migrating to Veeva Vault Safety is a critical step for life sciences organizations seeking compliance, scalability, and efficiency in pharmacovigilance operations. However, data migration presents unique challenges, from source-to-target mapping to data integrity and regulatory compliance. What’s Inside the Guide? Key Benefits & Challenges of migrating to Veeva Vault Safety Technical Approaches &…

The RSIDM conference brought together industry leaders to discuss the evolving landscape of regulatory affairs. As regulatory requirements grow increasingly complex, organizations must adopt new technologies and methodologies to maintain compliance and efficiency.
Here are Daelight Solutions’ takeaways.

Daelight Solutions recently performed a migration to Vault Safety. Discover some of the things we learned when performing this multi-year migration project.

Every clinical trial involves documents and data that must be managed compliantly. One way to accomplish this is using an electronic trial master file (eTMF) system.

Updating your Veeva Vault configuration ensures your system is optimized and fits your needs. Here are 5 strategies for making that happen.

Many life science organizations leverage Veeva Vault RIM. But even the most robust system needs occasional check-ups to maintain effectiveness.

Explore three reasons why companies deviate from the TMF Reference Model and why it’s best to scrap that custom TMF index.

Data migration depends upon thorough planning to mitigate risks, ensure data integrity, and comply with regulations.