Automating EDC user access for improved trial efficiency and compliance
Case study
Overview
In the highly regulated world of clinical drug development, secure and timely access to Electronic Data Capture (EDC) systems is essential. Manual processes can lead to errors resulting in data integrity risks, delays, and regulatory non-compliance. This case study highlights how ICON’s Clinical Data Science team automated EDC user access management to boost efficiency, reduce compliance risks, and scale operations.
Challenge
Managing user access to EDC systems is often manual and error-prone, leading to:
- Data integrity risks: Incorrect role assignments affect trial data quality.
- Compliance pressures: Failing to meet regulatory standards can result in costly delays or trial shutdowns.
- Time-consuming processes: Manual approvals and account setups slow onboarding.
- Scalability issues: Legacy processes struggle with growing trial demands
Solution
ICON developed a comprehensive solution using a cloud-based workflow platform and application programming interface (API) integrations with an EDC vendor. ICON’s Operational Product Management team and the EDC vendor’s technical teams collaborated closely from the outset of the project, along with representatives from Service Now, ICON’s workflow automation platform. Through regular strategy meetings, they held interactive reviews and created a Q&A log to ensure the API aligned with ICON’s business requirements. The EDC vendor then partnered with ICON’s Operational Product Management and Data Operations teams to implement the API across 208 ICON-owned URLs and establish a streamlined registration process for future URLs.
The key improvements included:
Automated access management
By transitioning from manual workflows to an automated ticketing system integrated with APIs, ICON reduced human error and improved processing time.
Dynamic role assignment
Real-time API connections ensured that access requests were validated instantly, preventing incorrect assignments and reducing role management errors across multiple systems.
Approval workflows
A two-stage approval process was implemented to enhance oversight and ensure that only authorised personnel could assign or revoke access, improving both security and compliance.
Faster onboarding
Automating the user account setup process reduced onboarding times from days to just 30 minutes per request, ensuring that teams could access the systems they needed without delay
Self-service portal
A self-service portal was introduced to allow users to request access directly, reducing the workload on IT teams and enabling quicker, more streamlined access requests.
Outcome
ICON’s collaboration to integrate the EDC vendor’s Clinical Cloud APIs with its workflow automation platform has led to more streamlined and enhanced User Access Management processes. We are now extending these efforts to other EDC vendors.
The implementation of automated EDC user access management has resulted in numerous benefits for study sponsors and clinical trial partners:
-
improved data integrity & security
Correct, consistent access assignments reduce risks and increase data security for more reliable data. -
enhanced compliance
Real-time documentation ensures regulatory adherence. -
increased efficiency
Tickets can be turned around in 30 minutes with significantly reduced error rates.
By automating EDC user access, ICON improved operational efficiency, security, and compliance while supporting the scalability needed for clinical trial success. This case study demonstrates how advanced technology can solve a key challenge in trial management, enabling faster, more accurate access provisioning and reducing costs.