Nextrove Managed Services
Nextrove extensive experience in drug safety and pharmacovigilance allows pharmaceutical companies to focus on their core mission of drug development and patient safety.
Nextrove managed services are tailored to meet the unique needs of the pharmacovigilance sector. Our services encompass system implementation, data management, regulatory compliance, and continuous support, enabling pharmaceutical companies to focus on their core mission of drug development and patient safety.
Nextrove services are designed to cut your system maintenance costs and deliver fast resolution to production issues, boosting your operational efficiency. With teams across the globe, we offer 24/7 access to our experts.
Whether you need technical assistance for ongoing configuration management or functional support to troubleshoot business issues, we’ve got you covered around the clock.
Partnering with Nextrove
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, update MedDRA, WHO Drug, and J Drug dictionaries, oversee ongoing product, license, study (PLS), and maintain reporting rules. 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 PMs, BAs, TAs, and QA/QC resources are available for temporary or long-term roles, acting on your behalf and working under your supervision.
Features
Partner with us for your pharmacovigilance IT managed services and leverage our comprehensive solutions to enhance the safety, compliance, and efficiency of your pharmacovigilance operations. Our commitment to excellence, coupled with our extensive industry experience, ensures that your organization is well-equipped to meet the challenges of modern pharmacovigilance.
Enhanced Compliance: Ensuring adherence to global regulatory standards, reducing the risk of non-compliance issues. Improved Efficiency: Streamlined processes and advanced technologies to enhance the efficiency of pharmacovigilance operations. Data Security: Robust security measures to protect sensitive pharmacovigilance data from unauthorized access and breaches. Scalability: Scalable solutions that can grow with your organization, accommodating increasing data volumes and regulatory requirements. Cost Savings: Reduced IT overheads and operational costs through efficient managed services and strategic IT investments. Expertise and Experience: Access to a team of experts with deep industry knowledge and technical expertise in pharmacovigilance IT solutions.
Discover how Nextrove can support your system maintenance and deliver fast resolution to updates and issues
Reach out to us today to arrange a consultation.
