Case Study: Enhancing Global Follow-Up Automation (GFA) for a leading US Pharma Company
Overview
In April 2024, a leading US Pharma Company launched the Global Follow-Up Automation (GFA), a solution that streamlined the creation and management of follow-up letters across 38 languages. After a successful launch, Phase 2 of the project was initiated in September 2024 with a focus to enhance both letter quality and tool usability, guided by users’ feedback and evolving business needs.
Objective
- Improve the quality of multilingual follow-up letters.
- Enhance the usability and editing capabilities of the tool.
- Implement prioritized change requests from the client.
Approach
Originally planned as a waterfall project, the Nextrove team adapted to client’s request for early previews of features by shifting to an agile delivery model. This allowed faster feedback loops and better stakeholder engagement.
Phased Development
Features were divided into three batches
Iterative Delivery
Each batch was developed, reviewed by the client, and refined based on feedback
Integrated Flexibility
Feedback from earlier batches influenced the development of subsequent ones
This approach allowed the client more time to finalize requirements for later changes while still staying within the overall timeline.
Challenges & Solutions
One of the key challenges in this project was balancing the need for flexibility with the discipline required to maintain control over a complex development process. While the original plan followed a more traditional waterfall methodology, expressed a strong preference for early visibility into new features — rather than waiting for the entire development cycle to complete. This request, though valuable from a user engagement perspective, introduced complexity in tracking development across multiple stages.
To address this, the Nextrove team made a strategic pivot to a more agile-inspired approach. Instead of bundling all changes into a single final release, the team divided the enhancements into three logical batches, developing and delivering each one sequentially. After each batch was deployed, the client had the opportunity to review the features, provide feedback, and suggest refinements which were then incorporated into the next round of updates.
While this iterative approach required careful coordination and meticulous change management, it ultimately allowed for more adaptive planning and stronger alignment with the client’s evolving priorities. It also gave the client team additional time to finalize their requirements for later phases, which proved especially helpful in a multilingual and highly regulated context.
Results
This flexible yet structured delivery method paid off in several important ways:
- The project was delivered on time and in accordance with the original plan, despite the mid-course shift in methodology.
- Client reported increased satisfaction with the tool’s usability, particularly the enhanced editing capabilities and overall letter quality.
- The collaborative, transparent process helped deepen the relationship with the client, reinforcing trust and paving the way for future work — including the upcoming Phase 3, which the client entrusted to the same team.
Client Feedback
The strongest validation came from client’s decision to launch Phase 3 — a significantly larger and longer initiative — and their specific request for the same project team.
Team Recognition
The success was made possible by the exceptional dedication and collaborative spirit of the team. The client specifically acknowledged the contributions of team members, highlighting not only their technical expertise, but also their responsiveness, adaptability, and commitment to excellence throughout the project lifecycle.
Shivi, Shoaib, Shubham P., Nazila, Anu, and Aparna each played a vital role in ensuring that the project met its goals — from managing complex multilingual requirements to navigating the shift toward an agile delivery approach. Their ability to stay focused under pressure, respond quickly to evolving client needs, and work cohesively was consistently recognized and appreciated by the client.
This recognition from the client reflects the strong working relationship built during the project and underscores the value of having a dedicated, cross-functional team that truly understands both the technical and business dimensions of the work. The client’s decision to request the same team for Phase 3 is a testament to the trust and confidence earned through their efforts.
Progressive Compliance Series - Episode 4: Advanced Reporting with Progressive Compliance
Transforming Compliance with Data-Driven Insights
Compliance management isn’t just about meeting deadlines—it requires insightful reporting to drive better decision-making. Progressive Compliance provides powerful reporting tools that help businesses to track performance, to analyze trends, and to optimize compliance strategies.
Key Reporting Capabilities
1. Comprehensive Draft Report Generation
- Quickly create aggregate reports that meet regulatory standards
- Reduce manual effort with pre-configured templates
2. Seamless Cloud Storage Integration
- Automatically save and organize reports in several platforms, as per client request
- Ensure secure and accessible documentation storage
3. Custom Reporting & Subscriptions
- Generate tailored reports on demand
- Schedule automated report delivery to key stakeholders
Driving Proactive Compliance Management
With these reporting capabilities, businesses can refine compliance processes, minimize risks, and enhance operational efficiency. Progressive Compliance enables organizations to move from a reactive to a proactive approach in regulatory documentation management.
What’s Next?
In an ever-evolving regulatory landscape, Progressive Compliance is the solution for organizations looking to stay ahead. Reach out now to requesto a demo
Progressive Compliance Series - Episode 3: Automating Compliance Workflows for Maximum Efficiency
The Power of Automation in Aggregate Reports Management
Manual processes are inefficient, prone to errors, and time-consuming. Progressive Compliance leverages intelligent automation to streamline generation and submission of aggregate reports ensuring accuracy and efficiency.
How Automation Works
1. Intelligent Task Assignment & Alerts
- Assigns tasks to the right team members based on compliance needs
- Sends proactive alerts to keep teams informed and on schedule
- Generates and integrates required data
2. Automatic Submission Record Creation
- Automatically generates submission records as deadlines approach
- Eliminates oversight and ensures timely regulatory submissions
3. Personalized Task Dashboards
- Provides real-time task tracking and performance insights
- Enables employees to prioritize and manage their workload effectively
Enhancing Efficiency & Strategic Focus
By automating routine tasks, Progressive Compliance reduces manual workload and allows teams to focus on strategic initiatives.
What’s Next?
In an ever-evolving regulatory landscape, Progressive Compliance is the solution for organizations looking to stay ahead.
In our final article, we’ll explore how Progressive Compliance integrates with advanced reporting and data analytics to enhance decision-making.
Progressive Compliance Series - Episode 2: A Tailored Approach to Aggregate Reports Compliance Management
Progressive Compliance offers a highly customizable solution that adapts to unique business needs, ensuring regulatory obligations are met efficiently. Progressive Compliance supports generation of aggregate reports and data export from safety systems for including into the target documents.
Key Customization Features
- Products and licenses configuration
- Tracking and scheduling obligations across multiple regions
- Document generation
- Teams and tasks management
- Customizable dashboards & reports for real-time analytics
- Audit ready
Scalable for Businesses of All Sizes
Whether a small business managing a handful of documents or a large enterprise navigating complex regulations, Progressive Compliance adapts to evolving needs.
Looking Ahead
In an ever-evolving regulatory landscape, Progressive Compliance is the solution for organizations looking to stay ahead. Stay tuned for our next article on how Progressive Compliance supports organizational needs.
Press Release: Nextrove Successfully Completes Global Safety Database Conversion for Leading South Korean Pharmaceutical Company
Nextrove Successfully Completes Global Safety Database Conversion for Leading South Korean Pharmaceutical Company
March 2025 - Seoul, South Korea
About Nextrove
Nextrove leads the industry in Pharmacovigilance Professional Services and Solutions. Our unwavering mission, “Empowering Clients to Improve Patient Safety,” propels us on the path to realizing our vision of becoming the first choice for Life Sciences professional services and solutions, in service of our clients, partners, and, above all, the patients we ultimately serve.
www.nextrove.com
info@nextrove.com
+1 347 551 1700
Nextrove LLC.
116 Village Boulevard,
Princeton Forrestal Village, Suite 208
Princeton, NJ 08540, USA
Nextrove Korea LLC
Room 909-A-28, D-dong,
30 Songdomirae-ro,
Yeonsu-gu, Incheon,
South Korea 21990
Nextrove is proud to announce the successful completion of the Global Safety Database (GSD) conversion project from Arisg 7.4.6.2.5 to LSMV for one of South Korea’s top pharmaceutical companies, a leader in innovative drug development with 26+ drug pipelines and a strong presence in Hypertension, Dyslipidemia, and gastroesophageal reflux treatments across domestic and international markets.
Through a rigorous verification process, the Nextrove team ensured zero (0) bugs during end-to-end validation, delivering a seamless and efficient transition.
Client Testimonial
The client expressed high satisfaction with Nextrove’s expertise and commitment:
“It was our pleasure to have you and your team on this project, and we truly appreciate your support and hard work. Nextrove’s team provided prompt responses and effective solutions, ensuring the successful completion of the LSMV conversion. Every member of your team demonstrated excellent service quality, knowledge, skills, and commitment. We also learned a lot from this collaboration and look forward to working together on future projects.”
A Commitment to Excellence
This milestone underscores Nextrove’s expertise in pharmacovigilance technology transformation, ensuring compliance, efficiency, and enhanced safety data management for global pharmaceutical operations.
We extend our heartfelt thanks to our dedicated team for their meticulous execution and to our valued client for their trust and collaboration. We look forward to continuing our partnership and delivering more innovative solutions in the future.
Progressive Compliance Series - Episode 1: Navigating Compliance Challenges
Businesses face mounting regulatory pressures, and failing to meet compliance obligations can lead to legal and financial risks. Managing these processes manually is complex, time-consuming, and prone to errors. Progressive Compliance, part of the Progressive Suite, provides innovative ways to generate aggregate reports, and simplifies compliance management with intelligent automation and streamlined workflows.
Built on the Power of Salesforce
Leveraging the Salesforce platform, Progressive Compliance ensures security, scalability, and accessibility, allowing teams to efficiently manage obligations and submissions.
Key Features
Intelligent Task Management
• Submissions schedule and aggregate reports calendar management
• Automated task assignments
• Proactive notifications of upcoming deadlines
Automated Compliance Tracking
• Auto-generated submission records
• Real-time monitoring of obligations
Advanced Reporting & Insights
• Seamless report generation
• Custom report subscriptions
Business Impact
Progressive Compliance transforms aggregate reports management by reducing manual work, minimizing risks, and improving efficiency. With automation and real-time insights, businesses can focus on strategic initiatives rather than administrative burdens.
Looking Ahead
In an ever-evolving regulatory landscape, Progressive Compliance is the solution for organizations looking to stay ahead. Stay tuned for our next article on how Progressive Compliance supports organizational needs.
Ensuring Global Compliance with Progressive Convey: Episode 5: Leveraging Progressive Convey for Data-Driven Decision Making
Compliance in clinical research is non-negotiable, with strict regulations governing every aspect of document distribution. Progressive Convey addresses this challenge by embedding compliance into its core functionalities. This article highlights how the platform simplifies adherence to global and local regulatory requirements.
Compliance-Driven Features:
- Worldwide Regulatory Adherence: Progressive Convey ensures that distributed documents meet the compliance standards of all regions, whether it’s GDPR in Europe, HIPAA in the US, or other country-specific requirements. Its ability to adapt to varying regulatory landscapes helps organizations maintain global consistency without compromising on local compliance.
- Configurable Workflows: The platform’s flexibility allows organizations to configure workflows to match their unique regulatory needs. Whether managing multi-country studies or single-site operations, Progressive Convey adapts seamlessly. This customization ensures that every distribution process adheres to relevant standards.
- Audit Trail and Transparency: Every action within the system is logged, creating a comprehensive audit trail. This feature ensures accountability and supports regulatory inspections, providing peace of mind for sponsors and investigators alike.
- Investigator Verification: To enhance security and compliance, Progressive Convey uses OTP (One-Time Password) authentication, ensuring that only authorized personnel access sensitive documents. This verification step mitigates risks of unauthorized access and data breaches.
Real-Time Monitoring and Reporting
Interactive dashboards and real-time reports provide insights into distribution progress and compliance status. Organizations can identify bottlenecks, address issues proactively, and ensure that no critical task is overlooked. Advanced analytics capabilities empower users to stay ahead of compliance challenges by offering actionable insights.
Let’s Get Started
Progressive Convey not only ensures compliance but also enhances transparency and efficiency in safety document distribution. It’s a comprehensive solution that empowers organizations to navigate the complex regulatory landscape with confidence and ease. By embedding compliance into its foundation, Progressive Convey enables organizations to operate seamlessly in a globally regulated environment.
Why Nextrove’s Managed Services Are a Game-Changer
Pharmaceutical companies are under constant pressure to innovate while maintaining compliance and efficiency. Nextrove’s Managed Services stand out as a vital partner for these organizations, offering unparalleled expertise, scalable solutions, and cost savings.
The Unique Advantages of Nextrove’s Managed Services:
- Enhanced Compliance: Minimize risks with solutions tailored to meet stringent regulatory requirements across regions.
- Improved Efficiency: Streamline processes with expert-led support, automation, and advanced technologies.
- Scalable Solutions: Adapt seamlessly to growing data volumes and complex regulatory needs.
- Uncompromised Data Security: Protect sensitive data with industry-leading encryption, access controls, and security protocols.
- Cost Savings: Achieve significant IT overhead reductions through efficient managed services and strategic technology investments.
Comprehensive Services for Every Need:
- Rapid Issue Resolution: Our dedicated teams work around the clock to address production issues promptly, ensuring minimal downtime.
- End-to-End Change Management: We manage the entire lifecycle of system changes, from gathering requirements to deployment.
- Advanced Analytics Expertise: Our team uses leading tools like Cognos, OBIEE, and BIP to deliver actionable insights that drive data-driven decision-making.
Real-World Impact:
One of our clients, a mid-sized biotech company, faced challenges in scaling their pharmacovigilance operations. By implementing Nextrove’s managed services:
Reporting timelines have been reduced by 40%
Compliance readiness has been enhanced
Seamless integration with existing safety systems has been achieved, improving overall efficiency.
Revolutionize your business today
With Nextrove’s Managed Services, pharmaceutical companies gain a trusted partner dedicated to optimizing pharmacovigilance systems. Our expertise, coupled with innovative solutions, ensures that your organization remains compliant, efficient, and ready to meet future challenges. Experience the benefits of compliance, efficiency, and innovation with Nextrove at your side.
Explore the Nextrove advantage today—because the future of your business deserves nothing less.
The Progressive Convey Series: Episode 4: Leveraging Progressive Convey for Data-Driven Decision Making
In today’s data-driven world, the ability to extract actionable insights from operations is a competitive advantage. Progressive Convey equips organizations with powerful reporting and dashboard features that turn raw data into meaningful metrics, enabling informed decision-making and continuous improvement.
Advanced Reporting Features:
- Pre-Configured Reports: Progressive Convey offers a suite of ready-made reports tailored to the needs of clinical research. These include distribution performance, investigator engagement, and compliance tracking, providing immediate value without additional configuration.
- Customizable Reporting Options: For organizations with specific needs, Progressive Convey allows users to create custom reports. This flexibility enables tracking of unique metrics, such as study-specific timelines or investigator responsiveness.
- Reconciliation Reports: Ensuring data accuracy is critical in clinical research. Progressive Convey’s reconciliation reports help identify discrepancies in distribution records, ensuring that all documents are accounted for and properly acknowledged.
Interactive Dashboards:
- Real-Time Data Visualization: Dynamic dashboards offer real-time insights into key metrics, such as distribution progress, investigator acknowledgements, and pending tasks. These visualizations make it easy to monitor performance and identify areas for improvement.
- Role-Based Access: Dashboards can be customized based on user roles, ensuring that each stakeholder has access to the most relevant data. This targeted approach enhances usability and efficiency.
- Automated Notifications: Users can set up alerts for critical thresholds or milestones, ensuring proactive management of potential issues before they escalate.
Subscription-Based Report Delivery
Progressive Convey supports scheduled report generation and delivery. Stakeholders can subscribe to regular updates, ensuring that they receive timely insights without needing to manually pull data.
Operational Impact
By leveraging these advanced reporting and dashboard capabilities, organizations can make data-driven decisions that improve compliance, efficiency, and overall performance. The insights gained empower teams to act proactively, rather than reactively, in managing safety document workflows.
Get Started Today
Progressive Convey transforms data into a strategic asset, enabling organizations to optimize operations and drive continuous improvement. Its robust reporting and dashboard features ensure that every decision is backed by accurate, real-time insights, making it an invaluable tool for modern clinical research.
Revolutionizing Pharmacovigilance with Nextrove’s Managed Services
Pharmaceutical companies face increasing challenges in maintaining robust pharmacovigilance systems that ensure patient safety and regulatory compliance. Nextrove’s Managed Services offer a transformative solution, enabling organizations to focus on their core mission: advancing drug development and enhancing patient care.
Key Challenges in Pharmacovigilance:
- Regulatory Complexity: Navigating the diverse and ever-evolving global regulatory requirements.
- Operational Inefficiencies: Manual processes and outdated systems leading to delays and errors.
- Cost Management: Balancing operational costs with the need for advanced technological solutions.
How Nextrove Transforms Pharmacovigilance Operations
- Streamlined Operations: Nextrove provides end-to-end support for pharmacovigilance systems, from implementation to ongoing maintenance, ensuring seamless operations.
- Expert-Led Solutions: Our global team of specialists delivers 24/7 support, ensuring fast issue resolution and system optimization.
- Cost Efficiency: By reducing system maintenance costs and resolving issues efficiently, we boost your operational performance while lowering overheads.
Core Services:
Issue Triage & Resolution:
Swift collaboration with IT and business teams to resolve issues within agreed SLAs. Documented fixes ensure transparency and reliability.
Configuration Maintenance:
Comprehensive support for E2B updates, EMA and FDA connectivity tests, workflows, templates, and more, ensuring systems are always up-to-date.
Change Management
From requirement gathering to deployment, we handle the entire change management process, ensuring smooth transitions with minimal disruption.
Revolutionize your business today
Nextrove’s Managed Services empower pharmaceutical companies to achieve enhanced compliance, improved efficiency, and cost savings. Let us handle the complexities of pharmacovigilance IT so you can focus on innovation and patient safety.
Explore the Nextrove advantage today—because the future of your business deserves nothing less.
