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.
The Progressive Convey Series: Episode 3: Integrations and Scalability, the Backbone of Progressive Convey
In the ever-expanding landscape of clinical research, scalability and integration are critical to managing increasing operational demands. Progressive Convey rises to the occasion by offering seamless integration with existing safety systems and unmatched scalability, ensuring that organizations can adapt and thrive in a competitive environment.
Seamless System Integration:
- Compatibility with Safety and Clinical Applications: Progressive Convey integrates effortlessly with widely used safety systems such as Argus Safety and ArisG. It can integrate with Clinical Operations applications to extract the target audience. This compatibility ensures smooth data exchange between platforms, minimizing errors and redundancies.
- Email-Based Workflows: By processing emails containing safety documents and case information, Progressive Convey intelligently prepares distributions. This feature reduces manual intervention and streamlines workflows, ensuring that critical documents reach the right stakeholders promptly.
- API Support for Custom Integrations: For organizations with unique requirements, Progressive Convey offers robust API support. This enables custom integrations with in-house systems, further enhancing operational flexibility.
Unmatched Scalability:
- Designed for Growth: Progressive Convey’s architecture supports organizations of all sizes, from small teams to large multinational enterprises. Its ability to scale ensures that increasing document volumes and users do not impact performance.
- Cloud-Based Scalability: Built on the Salesforce platform, Progressive Convey leverages cloud-based infrastructure to accommodate growing data needs without requiring additional hardware investments. This ensures cost-effective scalability for expanding operations.
- Future-Proofing with Regular Updates: Progressive Convey benefits from Salesforce’s continuous improvement model, ensuring that the platform evolves alongside industry advancements and regulatory changes.
Operational Benefits of Integration and Scalability
The seamless integration capabilities and robust scalability of Progressive Convey empower organizations to maintain efficiency, even as their operations grow. By reducing redundancies and ensuring system compatibility, the platform simplifies workflows and enhances productivity.
Get Started Today
Progressive Convey’s integration and scalability features future-proof safety document management processes. Its ability to seamlessly connect with existing systems while accommodating growth makes it an indispensable tool for modern clinical research organizations.
Press Release: Nextrove Successfully Hosts MedAssessment on AWS Cloud with Seamless Argus Migration
Nextrove Successfully Hosts MedAssessment on AWS Cloud with Seamless Argus Migration
January 2025
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 LLC is proud to announce the successful migration and hosting of MedAssessment, a leading global CRO, onto the Nextrove AWS Cloud. This achievement showcases Nextrove’s commitment to delivering innovative, scalable solutions and exceptional service in the field of pharmacovigilance.
The President of MedAssessment Peg Fletcher, MD, PhD expressed her satisfaction with the project:
"This has been the smoothest migration I have experienced. The professionalism, dedication, and teamwork of the Nextrove team ensured the project’s success from start to finish. We couldn’t have asked for a better experience!"
The three-month project was a collaborative effort between MedAssessment and Nextrove’s dedicated team, including Abhisek, Abhinay, Rudra, Nivedita, Javid, Shalet, and Sumit, whose exceptional contributions kept the project on track.
MedAssessment also praised Nextrove’s proprietary migration methodology for its precision and efficiency, highlighting the seamless execution and the consistent support provided throughout the migration process.
MedAssessment, Inc. is a US-based Contract Research Organization (CRO) specializing in pharmacovigilance and early drug development assessments. They provide a comprehensive range of services including safety monitoring, signal detection, and medical writing to drug sponsors and clinical operations teams. With a dynamic team of multilingual medical professionals, MedAssessment leverages advanced technology to streamline safety data management and ensure compliant regulatory submissions. Their expertise is particularly focused on early-stage clinical trials, aiming to deliver high-quality safety profiles to facilitate faster product approvals.
The Progressive Convey Series: Episode 2: Inside Progressive Convey’s Cutting-Edge Features
In a rapidly evolving clinical research landscape, technology is at the forefront of solving operational inefficiencies. Progressive Convey emerges as a leader with its array of advanced features, each designed to tackle specific challenges in document distribution. This article explores the key functionalities that make Progressive Convey a game-changer for organizations worldwide.
Progressive Convey Key Features
- Intelligent Report Distribution Engine: The backbone of Progressive Convey’s efficiency is its automation capabilities. By leveraging predefined criteria, the system ensures that reports are distributed accurately and promptly to the right stakeholders, eliminating manual delays and errors. It reduces operational burdens while enhancing the reliability of document handling.
- Multilingual Cover Letter Templates: Communication in a global environment often requires documents in multiple languages. Progressive Convey simplifies this process with customizable templates that can generate cover letters in various languages, ensuring effective and culturally sensitive communication. Templates can be tailored to specific regional needs, enhancing clarity and compliance.
- Integrated Communication Tools: A built-in email system streamlines interactions between sender and receiver. Notifications and reminders ensure that all parties remain informed, reducing bottlenecks in the communication chain. By consolidating communication within the platform, Progressive Convey minimizes the risk of lost or delayed correspondence.
- Secure Document Download Portal: Data security is paramount. Progressive Convey’s secure portal allows receivers to download documents with controlled access, ensuring confidentiality and compliance with global standards. This feature provides an additional layer of protection through optional OTP authentication for identity verification.
- Configurable Approval Workflow: Organizations can tailor approval processes to align with their specific needs, ensuring compliance with internal policies and regulatory guidelines.
Operational Impact
These features collectively enhance operational efficiency by automating repetitive tasks, improving communication, and ensuring secure document handling. By streamlining workflows, Progressive Convey enables organizations to focus on strategic objectives rather than administrative overhead.
Get Started today
By integrating automation, customization, and security, Progressive Convey’s cutting-edge features set a new benchmark for safety document distribution.
Experience the future of document management with Progressive Convey and revolutionize how your organization handles safety communication.