Leading multinational pharmaceutical company implements patient monitoring services
HCLTech helps client achieve 95% customer satisfaction and REMS compliance
A renowned pharmaceutical leader needed a partner to provide patient monitoring and medical information services for a specialty drug requiring risk evaluation and mitigation strategies (REMS) as recommended by the Medicines and Healthcare Products Regulatory Agency (MHRA). The goal was to mitigate life-threatening risks while ensuring patient safety and compliance.
The Challenge
Maintaining high standards of operational efficiency and an enhanced patient experience
Our client faced several critical challenges:
- Monitoring clinical and laboratory status: They need to continuously monitor patient's clinical and laboratory status while consulting with physicians to ensure adherence to treatment regimens. This requires a robust system capable of real-time data collection and analysis to provide timely interventions.
- Ensuring patient safety: The client tracks drug usage and adherence for every patient to mitigate potential risks. This involves developing a comprehensive tracking system to monitor patient behavior and provide alerts for deviations from the prescribed treatment plan.
- Regulatory compliance: Developing effective monitoring solutions that were compliant with regulatory standards was a significant challenge. The client must ensure that all monitoring activities adhere to the guidelines set by regulatory bodies such as the MHRA. A deep understanding of the regulatory landscape and the ability to implement solutions that meet these stringent requirements is required.
- Operational efficiency: Another critical challenge was maintaining high operational efficiency standards while managing a large volume of patient data. The client needed to streamline operations to handle the influx of data and ensure that all processes were efficient and effective.
- Enhancing patient experience: The client aimed to enhance the patient experience through streamlined monitoring and consultation. This involved developing user-friendly interfaces and providing patients with easy access to their health information and support services.
The Objective
A comprehensive monitoring program ensuring safety and compliance with REMS requirements
The client aimed to accomplish the following objectives:
- Ensure safety and compliance with REMS requirements
- Maintain high standards of operational efficiency
- Enhance the patient experience through streamlined monitoring and consultation processes
The Solution
Meet the client’s unique needs through comprehensive training and a customized approach
HCLTech implemented a tailored approach to address the needs of the client that included:
- Optimized customer support: HCLTech developed optimized customer support by overcoming barriers and ensuring steadfast adherence. This involved creating a robust support system that efficiently handled various patient inquiries and issues.
- Comprehensive training programs: The team aligned comprehensive training programs, including support for REMS training modules, certification and MHRA reporting and patient safety programs. This ensured that all stakeholders were well-informed and compliant with the necessary regulations.
- Procedures and process steps: HCLTech designed and implemented procedures and process steps in line with the ever-evolving service needs. This included creating detailed workflows and protocols to ensure smooth operations and quick response times.
- Booth support and representation: The team supported the client in multiple congresses and symposia. They handled medical inquiries and registered adverse events (AEs) and product quality complaints (PQCs), ensuring that the client's presence was well-managed and professional.
- Advanced tools and technologies: To support the solution, the tools needed include:
- eCPM: A REMS database for cost-effective patient monitoring
- Information Request Management System (IRMS): An information request management system for the medical information database
- Centers for Natural Resources and Development (CNRD): A central non-rechallenge database
- sFTP server: For secure storage of personal health information (PHI)
- Supported channels: Inbound/outbound phone, email/fax, voicemail and outbound follow-ups for correspondence and voice interactions
The Impact
Enhanced compliance, significant operational efficiency and high customer satisfaction
The collaboration with HCLTech yielded significant results for our client:
- Managed over 20,000 contacts per year
- Achieved 95% compliance with quality goals
- Improved customer satisfaction scores to over 95%
- Reduced the call abandonment rate to just 2%
By leveraging our expertise and cutting-edge tools, we ensured regulatory compliance, patient safety and operational efficiency for the client’s specialty drug monitoring program.
