It’s no secret that drug and device safety is of the utmost importance in today’s competitive life sciences marketplace, and Pharmacovigilance (PV) is a major component of an effective drug regulation system for evaluating and monitoring adverse events (AEs). The importance of PV to the healthcare industry is underscored by a few striking facts:
- Adverse events reported to the FDA increased at 13% CAGR from 2006-2014,and serious AEs increased by 15% during the same time period
- According to the Centers for Disease Control (CDC), adverse drug reactions account for 100,000+ deaths per year, making them one of top ten causes of death in the U.S.
- The growing number of ADRs and chronic diseases will increase the global PV market size, which is expected to reach $8.2 billion by 2022.
- High cost of managing AEs in-house
- Lack of internal resources to manage the huge AE workload
- Evolving and un-harmonized regulations
- Stringent reporting timelines
- Increased reporting of adverse events in social media and literature
- RPA-driven Case Processing
- Pharmacovigilance Center of Excellence (CoE) Services
- Safety Analytics, Risk Management, Signal Detection and Analysis
- Safety Data Management
- Social Media Integration with SAP HANA
The benefits of Syntel’s PV services include:
- Automated AE case processing through the SyntBots automation platform. SyntBots shortens processing time by as much as 30%, reduces cost and manual effort, improves quality by reducing human error, and enhances operational efficiency.
- Reduced costs enable you to fund new technology investments and optimize R&D processes such as clinical trial discovery and reporting.
- Unique factory-based operational model that balances efficiency, compliance, quality and effectiveness.
- Deep process experience in Individual Case Safety Report (ICSR) processing from sources including spontaneous, clinical trials, literature, solicited and social media for drugs, OTCs and medical devices.
- Robust experience in support, implementation, migration and customization of safety databases like Argus and ARISg
- Syntel’s scalable, knowledgeable global workforce enables more flexible engagement and pricing models.
- Delivers an audit-ready PV service platform that supports MHRA, EMA and FDA audits.