Adapting Clinical Trials for Every Sponsor: A BPM Success Story with Camunda

Context

The client, a leader in clinical trial management, had a comprehensive system that managed various aspects of studies, from data collection to analysis by specialized physicians. However, this legacy system faced limitations in adapting to diverse sponsor requirements and evolving therapeutic areas (e.g., cardiology, gastroenterology). In addition to their established Clinical Trial Management System (CTMS), the client sought an agile solution that would allow them to offer tailored study designs to sponsors, meeting complex demands with ease.

Challenge: Fragmented Processes and Inefficiencies

The client faced significant operational challenges due to:

• Multiple Systems: Reliance on different CTMS platforms for various studies, depending on therapeutic area requirements.

• Lack of Centralization: Manual processes like emailing files and handling data locally disrupted workflows and posed risks to data integrity.

• Sponsor-Specific Needs: Complex sponsor requirements demanded flexible study designs that existing systems could not easily accommodate.

This fragmented setup slowed operations, introduced risks to data accuracy, and made it difficult to adapt workflows efficiently to sponsor requirements. The challenge was to create a centralized solution with the flexibility to meet diverse study and sponsor needs.

Solution: Adaptive BPM Triggers Based on User Actions

To address these challenges, we built a new CTMS with Business Process Management (BPM) capabilities powered by Camunda. This adaptive solution streamlined workflows by allowing:

• Dynamic BPM Triggers: Actions like adding participants or submitting data automatically initiated pre-configured BPM workflows, ensuring seamless operation without requiring user interaction with the BPM.

• Tailored Processes: BPMs were customized per study to handle specific requirements, such as separate workflows for ECG and imaging data in complex studies.

• Scalable Design: A modular framework enabled processes to scale according to study complexity and sponsor requirements.

BPM is like a traffic controller for tasks in a business. It makes sure everything happens in the right order, at the right time, and involves the right people. Think of it as a smart checklist that not only tracks what needs to be done but also makes sure each step is automatically handed off to the right person or system, so nothing gets missed.

Key Features of the BPM-Enhanced CTMS:

• Automated Demographic and Eligibility Checks: Routine checks for participant data were automated, reducing manual intervention.

• Real-Time Progress Tracking: Teams gained instant visibility into study progress through automated status updates.

• Automatic Report Re-Generation: Updates to data triggered automatic re-analysis and report generation, ensuring accuracy and consistency.

These capabilities allowed the client to maintain operational excellence while offering tailored solutions to their sponsors.

Outcome

The implementation of the BPM-enhanced CTMS delivered transformative results:

Operational Improvements:

• Eliminated manual workflows through automation.

• Improved data accuracy and reliability, reducing errors.

• Enhanced transparency with real-time progress tracking and structured workflows.

Business Benefits:

• Sponsor Confidence: Sponsors gained a clearer view of the data pipeline, improving trust in study quality.

• Scalability: The client is now equipped to handle increased study demands while maintaining efficiency.

• Faster Turnaround Times: Automation reduced delays, enabling quicker study implementation.

By integrating flexible and adaptive BPM workflows, the client now delivers faster, more accurate results while meeting diverse sponsor and study requirements. This centralized solution positions them to remain competitive in a demanding clinical trial landscape.