Pharmacovigilance
At CareLyft, our Pharmacovigilance Solutions are designed to safeguard patient well-being while ensuring robust regulatory compliance across the entire product lifecycle—from development through post-marketing surveillance. We offer end-to-end services including adverse event reporting, signal detection, risk management, and regulatory submissions. Powered by a highly experienced team and advanced digital technologies with integrated AI/ML capabilities, our integrated approach enables seamless, compliant, and efficient safety operations. We partner with pharmaceutical companies to navigate evolving global safety standards, helping them protect patients, build trust, and deliver therapies responsibly at scale.
Individual Case Safety Report (ICSR) Processing
High-quality ICSR processing is fundamental to accurately assessing a medicinal product's risk-benefit profile and ensuring its safe use throughout the product lifecycle. In today's rapidly evolving regulatory and product landscape, precision, consistency, and compliance in case processing are more critical than ever.
Our ICSR services are designed to manage safety data from diverse sources including clinical trials, spontaneous reports, scientific literature, social media monitoring, digital health platforms, patient-reported outcomes, and electronic health records (EHRs) while meeting global and local regulatory expectations.
How CareLyft Supports ICSR Excellence
CareLyft's integrated processes and advanced systems enable:
- Identification and evaluation of adverse drug reactions and experiences
- Comprehensive medical assessment of safety information
- Proactive follow-up for missing or incomplete data
- Accurate and timely reporting within regulatory timelines
- AI-powered rapid case processing with automated data extraction and validation
- Predictive analytics for early signal identification
As a full-service pharmacovigilance partner, we continuously monitor regulatory changes and assess their impact on our operations—ensuring sustained compliance, inspection readiness, and audit confidence.
Expertise Across Product Types
Our teams bring deep experience across a broad range of therapies and technologies, including:
- Small-molecule drugs
- Vaccines
- Biologics and biosimilars
- Cell and gene therapies / Advanced Therapy Medicinal Products (ATMPs)
- Medical devices
- Combination products
Why CareLyft
Ongoing Pharmacovigilance Support
Safety Development & Enablement - Safety Development Plan execution including SOP authoring, safety data migration, system implementation, and comprehensive user training. Case Intake & Continuous Monitoring - End-to-end case intake and monitoring through dedicated call-centre operations covering Adverse Events (AEs), Product Quality Complaints (PQCs), and Medical Information (MI), including validity assessment, duplicate checks, reportability determination, and triage. Enhanced by real-time dashboards and AI-driven prioritization systems. AE / SAE Case Processing & Compliance - Complete lifecycle management of AE and SAE cases encompassing data entry, medical coding, narrative development, validation, medical review, regulatory submissions, follow-ups, and ongoing compliance management. Now incorporating machine learning-based coding accuracy and automated quality checks. Literature Surveillance & Safety Insights - Systematic literature screening, signal identification, and actionable safety insights to support proactive risk management and regulatory readiness. Augmented with automated literature mining and AI-powered trend analysis.
Integrated Pharmacovigilance Solutions
Aggregate Safety Reporting - Preparation and submission of global aggregate reports including DSURs, PSURs, PADERs, and PBRERs, in alignment with ICH, USFDA, EMA, and CDSCO requirements. Signal Management & Evaluation - Proactive signal detection, prioritization, and medical evaluation to support timely risk identification and informed regulatory decision-making. Enhanced with AI-driven disproportionality analysis, Bayesian modeling, and real-world evidence integration. Risk Management & Mitigation Programs - Development and maintenance of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) to ensure continuous benefit-risk optimization. Digital & Social Media Safety Surveillance - Advanced social media analytics for post-marketing surveillance (PMS) and identification of spontaneous adverse events, enabling real-time safety intelligence in today's digital-first ecosystem. Includes sentiment analysis, adverse event trend detection, and patient feedback integration. Real-World Evidence (RWE) Integration - Collection and analysis of real-world data from EHRs, patient registries, claims databases, and digital health platforms to enhance signal detection and enable dynamic benefit-risk assessments throughout the product lifecycle. Predictive Pharmacovigilance & Proactive Risk Mitigation - Leveraging AI and predictive analytics to anticipate potential safety risks before they escalate, enabling proactive intervention and mitigation strategies.