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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: March 08-2017 | By : Harish Rijhwani | In: Analytics,Digital Modernization,Healthcare Informatics,Innovation,Intelligent Business,Internet of Things,Mobility | 4 Comments

Did you ever think that one day your toothbrush would tell you if you have brushed your teeth well? Or for that matter your refrigerator would give an indication that you need to buy groceries. I never did but that is the world we are currently living in – Fast, ever evolving and always connected. To reach this point it has taken sometime and in this blog we will go back a little in time to understand how we reached the stage of being ever connected via – Internet of Things.

It was in 1969 when an experiment to connect two entities “Stanford University” and the “University of California” was conducted. After this in 1982 TCP/IP emerged as the protocol for ARPANET. This was the network to implement the basic communication language used on the Internet (TCP/IP protocol) and also use packet switching**. This was the basis of the Internet becoming a reality and the world slowly started to connect with each other. In the year 1989 Interop’s (Technology Conference) President Dan Lynch threw up a challenge to John Romkey to see if he could connect a toaster to the Internet. John worked with his friend Simon Hackett to connect a Sunbeam Deluxe Toaster to the internet. This was demonstrated in 1990 at the Interop Conference and became a huge hit/success. The solution at that point in time was not automated end-to-end since the bread still had to be put in manually. This was also automated by 1991 by adding a small robotic crane in the solution. It is very interesting to know that at the time this was achieved there were only 310K computers and only 3.1 million people had access to the internet.

There was no name given to this achievement and only in 1999 did Kevin Ashton coined the term “Internet of Things”. Evidently Kevin Ashton used the term as part of his presentation to Proctor and Gamble where he was linking the idea of using

RFIDs in P&G’s supply chain and the internet.  In the year 2000 LG came up with the first Internet connected refrigerator. It used RFIDs and barcodes to sense which items were in the fridge. This product was not very successful as it was expensive and also it did not solve any specific problems. A simple example, mostly all juice bottles are transparent one can visually decide if a purchase is required or not. Another aspect, which was in question was security, what if internet viruses would hack into your refrigerator system and open your fridge door. Today systems use Gmail to setup the same and one could hack into your email accounts if the system is weak. In the year 2005 United Nations globally recognized the Internet of things and also predicted that humans could be a minority as generators and receivers of traffic. Interesting to note the example quoted was of tiny sensors being used to check the Golden Gate Bridge (San Francisco) for structural damage. The list can go on and some of the more recent examples are Bluetooth enabled devices (mostly we all use one in our cell phones), self-driving vehicles, and google glass. When we look at the healthcare market it is expected to reach around $117 billion by 2020 along with this overall 40% of the IoT devices by then will be health related. I want to cite one specific example related to healthcare. If you are a fan of video games you would have heard of MYO a gesture controlled Armband. You can basically control your computer by waving your wrists to do things. Now you will ask me where is healthcare in this? Actually MYO armbands are used in physiotherapy treatments for fractures and measure how well the patient is responding to treatment. Well that is it for now, till next time. ** For those of you who don’t know packet switching is simply breaking the source message into smaller parts, sending it and reassembling it at the destination.   References http://www.computerhistory.org/internethistory/ http://www.postscapes.com/internet-of-things-history/ http://www.livescience.com/20727-internet-history.html http://www.baselinemag.com/networking/slideshows/a-brief-history-of-the-internet-of-things.html http://news.bbc.co.uk/2/hi/technology/4440334.stm  
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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: February 20-2015 | By : Sandeep Satyaprakash Mysore | In: Business Agility,Healthcare Informatics,Testing | 3 Comments
The U.S. healthcare model has achieved great technological advancements. The implementation of Electronic Health Record (EHR) systems has further streamlined care delivery. However, the focus so far has been on implementation and maintenance of technology. The need to document business processes in the provider environment, product optimization or testing EHR systems has taken a back seat.  
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Sandeep Satyaprakash Mysore
Sandeep is currently working as a Usability Analyst in the Healthcare domain, he has also been...

 
Posted on: January 29-2015 | By : Guninder Bhatia | In: Healthcare Informatics | No Comments

Over the last decade the U.S. healthcare industry has undergone a significant shift — transforming to be more consumer centric— to deliver quality care at low costs. However, according to the Performance in an Era of Uncertainty - The 17th Annual Towers Watson/National Business Group on Health Employer Survey on Purchasing Value of Health Care shows that the healthcare spend is increasing at a fast pace year on year.

 
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Guninder Bhatia
Guninder Bhatia works as a Business Analyst, Healthcare Practice with Syntel. She has over five...

 
 

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