Safety & Medical Writing
Pharmacovigilance & Medical Writing Services
eteraflex connects delivers end-to-end pharmacovigilance and medical writing services powered by intelligent safety monitoring and AI-driven documentation systems. With real-time safety oversight, predictive analytics, and globally compliant reporting workflows, we ensure faster submissions and world-class compliance.
Advanced Pharmacovigilance & Medical Writing for Every Phase
eteraflex connects provides a unified framework for clinical safety monitoring and regulatory documentation—combining AI-enhanced pharmacovigilance systems with automated medical writing workflows.
Our solutions support Phase I to Post-Marketing clinical programs across therapeutic areas including oncology, immunology, rare diseases, neurology, cardiology, and pediatrics.
Our Pharmacovigilance & Medical Writing Capabilities
Phase I–IV Safety & Documentation Programs
Our India-based clinical safety programs deliver full-cycle support through:
Safety Monitoring & AE Management
Specialized AI-enabled safety systems for real-time tracking, automated case processing, and global regulatory alignment.
Signal Detection & Risk Management
Machine-learning–based signal detection, periodic safety reports (PSUR/DSUR), and risk-management strategy development.
Regulatory Safety Reporting
Submission-ready safety docum- entation, SAE narrative preparation, and integrated audit-trail compliance across global authorities
Intelligent Resource Optimization
Automated document generation for protocols, CSRs, IBs, CTDs, IND/NDA/BLA submissions, and scientific publications.
Our services span full lifecycle safety and documentation—covering AE processing, regulatory writing, signal detection, and global submission support.
How We Deliver
eteraflex ensures seamless pharmacovigilance and medical writing execution through a structured and transparent framework:
- Dedicated Safety Project Management: End-to-end safety operations oversight and compliance tracking.
- Real-Time Safety Monitoring: Continuous AE/SAE processing with predictive alerting across all sites.
- Regulatory Coordination: Streamlined PSUR/DSUR submissions with 4–6-week delivery timelines.
- AI-Integrated Documentation: Automated content generation and cross-functional collaboration.
Our integrated approach accelerates reporting timelines, strengthens compliance, and ensures audit readiness across local and global programs.
Technology & Quality
ClinitraiX Safety & Documentation Platform—Built for Speed and Compliance
eteraflex connects uses the ClinitraiX platform to simplify and accelerate every safety and documentation workflow.
Technology Platform Integration
- Automated AE/SAE reporting
- 65% faster review cycles with AI-assisted processing
- Real-time dashboards for safety tracking
- FDA, EMA, CDSCO-compliant safety data packages
- Audit-ready database with complete traceability
Quality & Compliance Excellence
- Continuous audit tracking and inspection readiness
- Root-cause analysis and CAPA system integration
- Centralized safety oversight and risk detection
- Proven inspection pass rate across programs
- Ongoing quality improvement and regulatory monitoring
A Trusted Safety & Documentation Network Across India
Our clinical research network spans government medical colleges, specialty sites, and corporate hospital systems—supporting high-quality safety data capture and compliant documentation processes.
Robust Safety Infrastructure
Advanced diagnostic and reporting systems supporting comprehensive AE/SAE capture.
High-Performance Safety Sites
Sites with strong patient retention and consistent safety data integrity.
Standardized Quality Framework
Uniform safety and documentation standards applied across 240+ validated centers.
