Egnyte Case Studies Endpoint Clinical Enhances Audit Data Submission Compliance with Egnyte

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	Endpoint Clinical Enhances Audit Data Submission Compliance with Egnyte Egnyte

Endpoint Clinical Enhances Audit Data Submission Compliance with Egnyte

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
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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

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

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.

About 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.

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.

Impact #1	The Audit Data Management solution, powered by Egnyte, has enabled Endpoint Clinical to streamline operations for their clients at a critical juncture in the clinical trial process. The benefits extend to a wide variety of stakeholders including sponsors, investigators, and regulators. Sponsors can now fulfill their obligation to provide oversight without being an intermediary, and can receive assurances of ALCOA-plus principles while keeping a safe enough distance from the delivery of audit data to ameliorate any concerns about data integrity. This has made Endpoint Clinical uniquely capable of overcoming a particularly vexing compliance challenge in the current digital era of clinical research. The impact to their business is significant, with sponsors and investigators alike now eager to work with them.

Impact #1

The Audit Data Management solution, powered by Egnyte, has enabled Endpoint Clinical to streamline operations for their clients at a critical juncture in the clinical trial process. The benefits extend to a wide variety of stakeholders including sponsors, investigators, and regulators. Sponsors can now fulfill their obligation to provide oversight without being an intermediary, and can receive assurances of ALCOA-plus principles while keeping a safe enough distance from the delivery of audit data to ameliorate any concerns about data integrity. This has made Endpoint Clinical uniquely capable of overcoming a particularly vexing compliance challenge in the current digital era of clinical research. The impact to their business is significant, with sponsors and investigators alike now eager to work with them.

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Overview

Endpoint Clinical Enhances Audit Data Submission Compliance with Egnyte

Operational Impact