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Posted on: June 06-2017 | By : Dr. Rohit Sharma | In: Analytics,Big Data,Business Agility,Digital Modernization,Digital Solutions,Healthcare Informatics,Life Sciences | No Comments
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.
Pharmaceutical and Medical device manufacturers face a number of AE-related challenges, including:
  • 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
Syntel is here to help, with Pharmacovigilance services that balance innovation and risk, while providing the fastest case processing and the highest quality. Syntel’s PV offerings for adverse events include:
  • RPA-driven Case Processing
Syntel’s automated case processing takes AE cases from multiple sources and feeds data directly into your safety database, with integration and real-time information exchange between stakeholders. It also eliminates manual data entry for higher productivity, quality and efficiency.
  • Pharmacovigilance Center of Excellence (CoE) Services
Our PV CoE provides end-to-end adverse event case processing, including case intake and triage, medical coding and narrative writing and aggregate reporting.
  • Safety Analytics, Risk Management, Signal Detection and Analysis
  • Safety Data Management
Global safety database migration, implementation and validation
  • Social Media Integration with SAP HANA
Screens social media, performs text and sentiment analysis, and reports on tweet density, trend analysis, and ADR severity   analysis. How the SyntBots® automation platform powers PV:

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.
References:    
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Dr. Rohit Sharma
Dr. Rohit Sharma is a Pharmacovigilance Consultant, Life Sciences, Syntel. He is Dentist by...

 
Posted on: November 23-2016 | By : Harish Rijhwani | In: Analytics,Big Data,Digital Modernization,Digital Solutions,Intelligent Business | 2 Comments
The global healthcare analytics market is projected to reach around $23 billion by the year 2020. While the banking and retail industry has been using analytics for a long time, the healthcare industry has recently adopted this technology. A simple example can explain this, have you ever used your credit/debit card multiple times in a span of say five – ten minutes with the amount being substantially high? Well I have J and within two minutes of the transactions I received a call from the bank asking me if I was using my debit card or I have misplaced it.
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Harish Rijhwani
Harish C. Rijhwani is a Delivery Manager at Syntel with 14+ years of experience in Healthcare...

 
Posted on: September 22-2015 | By : Deepika Das | In: Analytics,Big Data,Business Agility,Digital Solutions,Enterprise Technology,Healthcare Informatics,Regulation and Compliance | 2 Comments

The significance of personalized medicine/precision medicine and its benefits is still new to the masses. However, the number of personalized medicine products has more than quadrupled in recent years. From the meagre 13 personalized medicine products available in 2006 to more than 70 in 2012, experts predict the American market for these drugs will double - increasing the market share from $9.2 billion in 2013 to $18.2 billion in 2019.
 

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Deepika Das

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Deepika Das
Dr.Deepika a Dentist by profession, and an MBA in Healthcare IT has around 3 years of experience in...

 
Posted on: March 20-2014 | By : Harish Rijhwani | In: Healthcare Informatics | No Comments
Post October 2014 Providers are mandated to use only ICD-10 codes for billing. ICD-9 to ICD-10 migration is a huge change for the healthcare industry. Separately, in Meaningful Use Stage 1 healthcare providers used to capture patient information using ICD-9 or SNOMED CT, but for Stage 2 they need to use only SNOMED CT.
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Harish Rijhwani
Harish C. Rijhwani is a Delivery Manager at Syntel with 14+ years of experience in Healthcare...

 
Posted on: February 15-2013 | By : Kunal Sawant | In: Healthcare Informatics | No Comments
The need to have accurate patient health information for clinical decision-making can hardly be over-emphasized. This is most evident when a patient is away from a healthcare facility and hence tracking and aggregating data of his vitals, lab tests and other physiological parameters becomes a challenge. While this has now been simplified with the use of a variety of home monitoring devices, it's the integration of these devices with applications that are accessible to both the patient (at home) and the providers (in the hospital or physician offices) that still present a problem.

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Kunal Sawant

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Kunal Sawant
Dr Kunalsen Sawant is medical physician with more than a decade of experience working with...

 
 

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