100% regulatory compliance for global contract research organization
Comprehensive REMS registry implementation leads to improved operational efficiency and customer satisfaction
Overview
Our client, an organization specializing in late-stage clinical trials, sought a partner to provide a personalized Graphical User interface (GUI) for sponsors and Risk Evaluation and Mitigation Strategy (REMS) administrators. The goals include reducing maintenance costs, managing audit trail tracking and enabling quick duplication of programs for new REMS launches.
The challenge
Operational inefficiencies and compliance needs in clinical trial processes
Our client faced several critical challenges that hindered their operational efficiency and compliance:
- Lack of visibility across registration processes: They struggled with inadequate visibility into various registration processes, including deactivation, activation and NC-CAPA tracking. This lack of transparency made monitoring and managing these processes difficult.
- Manual management of hospital registry data: The hospital registry data was managed manually, which was time-consuming and prone to errors and inefficiencies. This manual approach led to data inconsistencies and operational delays.
- Cumbersome and expensive platform: The existing platform hindered the client's ability to operate efficiently and adapt quickly to changing requirements.
- Complex manual tracking of NC-CAPA processes: The client had to manually track NC-CAPA processes to meet compliance needs, which was complex and error-prone. This led to potential compliance issues and delays in corrective actions.
- Inefficient order management processes: Order management processes were carried out manually using Excel. This approach resulted in inefficiencies and increased the risk of errors in processing.
- Inability to track and manage audit trail reports: The inability to effectively monitor audit trails led to delays in taking corrective actions and compromised compliance.
The objective
An automated, efficient and scalable system to enhance visibility and streamline processes
Our client turned to HCLTech to help:
- Enhance visibility across the REMS registry
- Streamline and digitize manual processes to ensure accuracy and compliance
- Reduce operational costs and improve ease of program duplication for REMS launches in the future
The solution
An automated platform to enhance operational efficiency and compliance
HCLTech delivered an innovative, end-to-end solution customized to meet our client’s needs:
- Deployment of an advanced platform: A low code/no code platform was deployed, enabling administrators to independently manage changes without relying on the IT team. This platform streamlined operations and reduced the dependency on technical support.
- Digitization of the REMS registry: An automated system for the REMS registry and program visibility was introduced. This digitization ensured accurate and efficient registry management, enhancing overall transparency and control.
- Automation of action workflows: The approver action workflow was automated, providing a responsive application for performing actions such as activation, reactivation and deactivation. This automation significantly reduced manual efforts and improved process efficiency.
- Automated NC-CAPA with necessary audit checks: The NC-CAPA processes were automated, incorporating necessary audit checks to ensure compliance and accuracy. This automation minimized errors and streamlined compliance tracking.
- Streamlined order management: Order entry processes and distributor mapping was automated, minimizing errors and improving efficiency. This automation reduced the reliance on Excel sheets.
- Enhanced audit trail capabilities: Audit trail tracking capability and a dashboard were enabled, along with email notifications for timely action and effective monitoring. This enhancement ensured that all actions were tracked and monitored efficiently.
Tools and technologies used:
- Cloud platforms: AWS, Azure and Google Cloud
- Programming languages: Java, Python and JavaScript
- Frameworks and libraries: React, Angular, Node.js and Spring Boot
- Databases: Oracle, SQL Server and PostgreSQL
The impact
Enhanced compliance, significant operational efficiency and high customer satisfaction
The solution delivered remarkable results for the client:
- Enhanced patient support: The system supported approximately 1,000 patients monthly, ensuring consistent and reliable operations for site personnel and patients. This level of support is crucial in maintaining the integrity and efficiency of the clinical trials, providing patients with the necessary resources and assistance throughout the process.
- Improved response time: The solution achieved a prompt response time of less than 20 seconds, significantly enhancing the experience for healthcare professionals (HCPs). This improvement in response time allows HCPs to access and manage information quickly and efficiently, leading to better patient care and streamlined operations.
- Scalable operations: The system enables scalable operations, supporting two new studies in the US and globally. This scalability ensures that the client can expand their research efforts without compromising quality or efficiency, allowing for a broader impact on the global healthcare landscape.
- Regulatory compliance: The solution ensured 100% compliance with regulatory requirements. This compliance is critical in maintaining the client's reputation and avoiding legal or operational setbacks. The automated processes and audit trail capabilities provided a robust framework for meeting all necessary regulations.
- Technological transformation: The solution transformed the client's REMS registry processes with advanced technology and seamless automation. This transformation drives efficiency, compliance and scalability, positioning the client as a leader in their field. Integrating cutting-edge tools and technologies enables the client to stay ahead of industry trends and deliver superior results.
HCLTech revolutionized the client’s REMS registry by integrating advanced technology and seamless automation. Leveraging a low-code/no-code platform, we streamlined workflows, enhanced audit trails and delivered measurable gains in efficiency, compliance and scalability. This transformation empowered the client to respond faster to regulatory demands while improving operational resilience.
