Delivering safety throughout the product development life cycle with Clinical Pharmacovigilance Services

• Dedicated Point of Contact: A single liaison between your organization and the Navitas Life Sciences’ team ensures seamless communication and coordination.
• Proactive Governance: A robust two-tiered governance structure with transparent communication channels and escalation processes.
• Quality and Risk Management: Adherence to ISO 9001:2015 and ISMS 27001 standards ensures risk identification and mitigation through comprehensive Quality Management Systems (QMS) and Information Security Management Systems (ISMS).

• Role Definition: Clearly defined roles, responsibilities, processes, and timelines for all clinical PV activities.
• Technology Utilization: Establishing the appropriate safety technology for your study.
• Regulatory Compliance: Meeting all safety reporting regulatory requirements with defined timelines.

• Automated Systems: Our world-class safety database handles daily case processing with automated assessments, auto-narratives, and auto-labeling.
• safetyREADY^® Suite
  • INTAKE: Automated case intake using Robotic Process Automation (RPA), Machine Learning (ML), and Natural Language Processing (NLP).
  • QC: Ensures data quality and uniformity across case processing operations.
  • Analytics: Comprehensive informatics ecosystem with dashboards for case monitoring, standard listing, and on-demand reports.
  • Signal: Cost-effective platform supporting signal detection and management.

• Clinical PV database to consolidate safety data from multiple studies, regardless of how many CROs are involved. With this single platform we facilitate standardized recording and reporting, real-time access, and streamlined collaboration for all users.
• Our safetyREADY^® suite of products automates all facets of clinical PV case processing and reporting including: Analysis of Similar Events (AOSE), narrative writing, report distribution to sites and committees, and reconciliation.

• Custom Solutions: Tailored safety reporting strategies, regulatory compliance, and implementation of SAE reporting systems.
• Training and Tools: Easy-to-use smart forms of electronic Case Report Forms (eCRF) for effective data capture and reporting.

• Safety Review Meetings are critical touchpoints in a clinical trial’s lifecycle. We handle all the logistical aspects to ensure that meetings are efficient, productive, and smoothly coordinated. We develop and manage the charter for Safety Review Meetings, schedule meetings, prepare and distribute material, coordinate, and execute meeting minutes and post-meeting follow-up.

• 24/7 Case Management: Comprehensive intake, reconciliation, and quality review processes supported by advanced PV technologies.
• Medical Review: MedDRA and WHO DD Coding, automated triage, narrative review, and effective query management.

• Causality Verification: Medical review to ensure correct and plausible causal relationships, expectedness, and reportability.
• Narrative Coherence: Ensuring medical coherence in coding and case narratives.

• Automated Distribution: Efficient submission of individual and aggregate safety reports to all relevant stakeholders, including: sites, partners, health authorities, and ethics committees. In addition, we monitor receipt with confirmation required from all stakeholders.

• Global Monitoring: Up-to-date monitoring of National Competent Authority websites, providing swift interpretation and strategic adjustments to minimize risk

• Periodic Activities: Regular signal management and recommendations based on comprehensive data reviews.
• Product Specific Calendars: Maintenance of signal calendars tailored to your products.

For further information on our Signal Management as a Service offering please click here.