In today’s fast-paced regulatory environment, the ability to manage safety systems efficiently and effectively is critical for pharmaceutical and life sciences organizations. Nextrove delivers a robust suite of services designed to streamline operations, ensure compliance, and drive informed decision-making. From issue resolution to advanced analytics, Nextrove’s expertise empowers businesses to meet the challenges of modern pharmacovigilance (PV).
Our Managed Services span a comprehensive range of operations, tailored to meet the unique needs of the PV sector. By leveraging our global expertise, companies can strengthen their PV infrastructure, ensuring all systems and processes align with industry best practices and international regulatory standards.
Swift Issue Triage and Resolution
When time-sensitive issues arise, they can disrupt workflows and jeopardize compliance. Nextrove collaborates closely with your business and IT teams to rapidly identify, prioritize, and resolve problems within agreed Service Level Agreements (SLAs). Our experts meticulously document each resolution and deploy fixes in accordance with your Standard Operating Procedures (SOPs), ensuring consistency and reliability.
Routine Updates to Stay Ahead
Keeping pharmacovigilance systems current is essential for maintaining compliance. Nextrove proactively manages routine updates, including:
- Administering access controls
- Updating key dictionaries such as MedDRA, WHO Drug, and J Drug.
- Managing products, studies, and reporting rules.
These updates ensure your systems remain aligned with evolving industry and regulatory requirements, minimizing risks and improving operational readiness.
Comprehensive Configuration Maintenance
As regulations evolve, system configurations must adapt. Nextrove provides full-spectrum maintenance services to keep your systems optimized, including:
- E2B updates and ESM profile modifications.
- Axway partner integrations and pilots with regulators such as EMA, FDA, and Chinese authorities.
- PMDA connectivity tests and updates to reporting destinations.
- Workflow adjustments, field validations, narratives, and letter template updates.
Our tailored approach ensures seamless operations across diverse regulatory frameworks and geographies.
Efficient Change Management
Change is an inevitable part of pharmacovigilance, and Nextrove specializes in managing it effectively. We follow client-specific or internal SOPs to oversee every step, including:
- Requirement gathering and analysis.
- Implementation, validation, and deployment across all environments.
This structured methodology minimizes disruptions and ensures the successful integration of new processes and technologies.
Advanced Reporting and Analytics
Accurate reporting and actionable insights are critical for informed decision-making. Nextrove offers an extensive range of reporting and analytics services, including:
- Ad-hoc reporting and audit /inspection preparation.
- Aggregate reporting, such as PADER, PBRER listings, CIOMS II Line Listings.
- Monthly signal detection reports.
- Advanced metrics and dashboards using tools like OBIEE, BIP, BO, Cognos, and SQL queries.
These capabilities enable organizations to improve operational efficiency while making proactive, data-driven decisions.
Key Solutions
Issue Triage & Resolution
We collaborate with your business and IT teams to swiftly triage and resolve issues within agreed SLAs. Our team documents fixes and deploys them according to your SOPs.
Routine Updates
We manage access and audits, update MedDRA, WHO Drug, and J Drug dictionaries, and oversee ongoing product, study, and reporting rules management.
Configuration Maintenance
Our services include E2B changes, ESM profile updates, Axway partner updates, E2B pilots with the EMA, FDA, and China, PMDA connectivity tests, and updates to reporting destinations, email recipients, workflows, field validations, narratives, and letter templates.
Change Management
We execute change management using client or internal SOPs, leading requirement gathering, analysis, implementation, validation, and deployment across all environments.
Reporting and Analytics
We handle ad-hoc reporting requests, audit support, aggregate reporting (PADER, PBRER listings, CIOMS II, and Line Listings), monthly signal reports, and advanced metrics using OBIEE, BIP, BO, Cognos, or SQL queries.
Staff Augmentation
Enhance your team with Nextrove’s skilled professionals from the US, Canada, EU, China and India. Our resources are available for temporary or long-term roles, acting on your behalf and working under your supervision.
Staff Augmentation with Global Expertise
Pharmaceutical companies often require flexible access to skilled professionals. Nextrove provides highly trained experts from the US, Canada, EU, China, and India for both temporary and long-term engagements. These professionals integrate seamlessly into your teams, working under your supervision while delivering expertise tailored to your specific needs. With global reach, we ensure your organization has the right talent at the right time.
Why Partnering with Nextrove?
Key Advantages
Enhanced Compliance
Improved Efficiency
Data Security
Scalability
Cost Savings
Expertise and Experience
Nextrove’s Managed Services are designed to enhance compliance, and efficiency of your pharmacovigilance operations, allowing your organization to focus on innovation and patient care. As the healthcare landscape grows more complex, robust PV systems are critical for managing safety data and ensuring regulatory adherence.
- Enhanced Compliance: We help organizations meet stringent global regulatory standards, and ensuring operational continuity.
- Improved Efficiency: By streamlining processes and deploying advanced technologies, we minimize manual tasks and enable teams to focus on high-value safety assessments.
- Data Security: Protecting sensitive information is a cornerstone of modern pharmacovigilance. Nextrove implements robust measures to safeguard data and prevent breaches.
- Scalable Solutions: Our services are designed to grow with your organization, adapting seamlessly to increasing data volumes and evolving regulatory demands.
With a global presence and extensive industry experience, Nextrove equips pharmaceutical companies with the tools and expertise to build resilient PV systems that address today’s challenges while preparing for future growth.
Partner with Nextrove for Pharmacovigilance Excellence!
Nextrove is your trusted partner in navigating the complexities of pharmacovigilance. Whether you’re managing routine operations, implementing strategic changes, or enhancing analytical capabilities, we deliver solutions that drive results.