PMS, Pharmacovigilance and Medical Writing

Reduce Risk and Boost Efficiency with Automated PMS and Vigilance Solutions from Syntel

Digital Services

Overview

For life sciences companies across the globe, safety is always the prime concern, but reporting complaints and adverse events is a challenging and cumbersome process for any enterprise. When your reputation hinges on the quality of your drugs or devices, you can’t leave anything to chance in today’s highly regulated safety environment.

Syntel offers an advanced suite of end-to-end services for complaints management, medical device reporting and pharmacovigilance that enables you to manage complaints and adverse events quickly, efficiently, and cost effectively — from clinical trials through to post marketing surveillance.

Powered by the SyntBots intelligent automation platform, our solutions enable clients to manage adverse event cases, medical coding, narrative writing, MDR consulting, reporting, and regulatory submissions at a lower cost and higher quality than they thought possible.

We also have extensive experience in medical writing, with the ability to deliver clear, concise, polished materials for multiple therapeutic areas. Every document produced by our experienced Medical Writing team undergoes a thorough scientific and quality control review process to ensure it meets your needs.

Offerings

Automated PV Case Processing

  • RPA-driven adverse event case processing
  • Data and application integration for real-time information exchange 
  • Data entry automation
  • Case intake and triage
  • Medical coding and narrative writing
  • Aggregate Reporting (PSUR, DSUR preparation and submission)

Adverse Event & Complaint Management

  • Complaint analysis & management
  • CAPA management
  • Risk management 
  • Signal intelligence
  • Field safety corrective action and field safety notice

Electronic Medical Device Reporting

  • Retrospective analysis of complaint files
  • Data and information gap identification
  • Updating complaint files
  • Form 3500A support
  • Regulatory report generation and submission 

Safety Data Management, Analytics and Risk Management

  • Global safety database migration, implementation and validation
  • Signal detection and analysis

Consumer Complaint Support

  • IVR integration support
  • Local language support
  • Consumer complaint tracking and reporting
  • Priority complaint tracking and escalation

Social Media Integration

  • Integration with SAP HANA
  • Social media screening and data aggregation
  • Text and sentiment analysis 

Safety Surveillance and Reporting

  • Periodic summary reports
  • Trend reports
  • Device vigilance SOPs
  • Follow-up reports
  • Clinical evaluation reports

Medical Writing

  • Clinical and regulatory writing
  • Synopses, protocols, brochures and forms
  • Medical safety narratives and reports
  • Common Technical Documents
  • Clinical study reports
  • Conference materials and manuscripts
  • Website content, CME, educational and marketing material
  • Scientific writing

The Syntel Advantage

  • Robust “quality by design” methodology to achieve 99%+ quality and compliance
  • 25–30% faster case processing with reduced manual efforts and greater operational efficiency powered by SyntBots
  • Global footprint for scalability and flexibility, and a wide range of commercial and governance models to meet your needs and requirements
  • Unique factory-based operational model for balancing efficiency, compliance, quality and effectiveness.
  • Deep experience with safety database (Argus, ARISg) implementation, data migration, and customization
  • Audit-ready service platform that supports MHRA, EMEA and FDA audits
  • Unique Service Management Framework for medical writing
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