11 Aug

The FDA Just Launched Operation TrialBlazer: Is Your Clinical Trial Archive Ready to Keep Up? Clinical development is becoming increasingly data-intensive, making data retention and lifecycle management important considerations for pharmaceutical organizations. Operation TrialBlazer's goal of modernizing clinical development adds further importance to efficient information infrastructure.

What Is Clinical Trial Data Retention?

Clinical trial data retention is the controlled preservation of clinical information for the period required by applicable regulations, contracts, policies, or business needs.

Why Is Retention Important?

Organizations need to distinguish between information that must be retained and information that no longer has a legitimate retention requirement.

How Does Retention Fit Into the Data Lifecycle?

A typical lifecycle may include:

  1. Creation
  2. Active use
  3. Controlled storage
  4. Archiving
  5. Retention
  6. Disposition

Why Is Manual Retention Management Difficult?

Large organizations may have thousands of studies and millions of records.

Can Automated Policies Help?

Organizations can evaluate automated retention and lifecycle policies to reduce manual administrative work.

How Can Solix Support Information Lifecycle Management?

Solix provides information lifecycle management capabilities designed to help organizations manage data throughout its lifecycle.

Frequently Asked Questions

What is clinical trial data retention?

It is the controlled preservation of clinical information for required periods.

Why should pharma companies automate retention?

Automation can reduce manual effort and improve consistency when managing large information environments.

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