Life Sciences

Problem:

A Mandate To Change

Clinical operations are being challenged by a 10-12% increase in clinical trials each year. To compound the problem, the complexity of many trials are also increasing with more data sources, decision points and regulations. The only way to meet sponsor expectations and accelerate Study Start-up processes is to simplify the integration and automation of applications and processes.

Manual and redundant data entry is time-intensive, error-prone and leads to poor data quality.

Before:

3 Applications: EDC, CTMS and Safety

The Clinical Research Associate manually enters the Severe Adverse Event (SAE)

• EDC emails to Drug Safety Admin.
• 20 min./SAE redundant data entry
• Manual entry to CTMS and Safety System
• ++ Additional minutes for updates
• 3-8 hours/month App reconciliation
• Plus 8 hours/month – Preparation for manual report data extraction from EDC

Increased time and cost of trial

After:

Align assets with efficient processes

The Clinical Research Associate manually enters the Severe Adverse Event (SAE)

• EDC automatically populated
• Zero redundant data entry
• CTMS and Safety system seamlessly populated
• Time gained for other tasks
• Eliminated monthly App reconciliation
• Eliminated preparation for manual report data extraction from EDC

Enable more efficient processes

Solution:

Empower ClinOps

The AXP solution accelerates the process by streamlining the creation of robust integrations with guided process automation. AppBus dramatically increases the speed of study start-up as our integrations don’t require application modification. AppBus ushers in a new era of Clinical Operation optimization to ensure positive business outcomes in R&D, Clinical and Commercial areas.

Human and machine collaboration – drive efficiency and effectiveness of clinical operations

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