Endpoint Clinical Enhances Audit Data Submission Compliance with Egnyte
Technology Category
- Cybersecurity & Privacy - Endpoint Security
- Cybersecurity & Privacy - Security Compliance
Applicable Industries
- Life Sciences
- Transportation
Applicable Functions
- Logistics & Transportation
- Quality Assurance
Use Cases
- Leasing Finance Automation
- Regulatory Compliance Monitoring
Services
- Cloud Planning, Design & Implementation Services
- System Integration
About The Customer
Endpoint Clinical is an Interactive Response Technology (IRT) provider based in Wakefield, MA. The company employs 600 people and operates in the life sciences industry. Endpoint Clinical's clients are involved in clinical trials, and the company's role is to streamline the provisioning of audit trail data to investigators and regulators in an increasingly computerized clinical trial landscape. This is done with the aim of achieving more effective and accurate compliance for all stakeholders. The company's challenge was to reduce risks to data integrity at trial closeout while maintaining the necessary oversight from trial sponsors.
The Challenge
Endpoint Clinical, an Interactive Response Technology (IRT) provider, was faced with the challenge of maintaining data integrity at trial closeout. The company typically provided audit data to investigators through the trial sponsor, who acted as an intermediary. However, this process raised regulatory concerns around data integrity due to the potential conflict of interest of sponsors who have a vested interest in gaining market approval of the products being studied. Regulatory bodies preferred to restrict audit log data to more neutral parties to avoid any possibility of data being modified to support approval. However, completely excluding sponsors from the process was not a viable solution as they still needed to have oversight of the overall process. Endpoint Clinical was tasked with finding a way to strike a balance between providing sponsors the oversight they need without making regulators uncomfortable.
The Solution
To address this challenge, Endpoint Clinical partnered with Egnyte to build a platform that would enable them to provide audit trail data directly to investigators, without hands-on involvement from the sponsor. The Audit Data Management platform, powered by Egnyte’s cloud file solution, delivers three key benefits. First, it ensures GxP compliance by capturing data that is traceable, accountable, and complete, and provides full visibility into how the data has been altered and who has accessed it. Second, it provides controlled access to site-specific data, with granular permissions controls ensuring that the data is only accessible to the proper stakeholders and in the proper manner. Lastly, it gives sponsors peace of mind by providing documented proof that the audit log was distributed to the investigator, confirming that everything was handled properly without their direct involvement.
Operational Impact
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