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

Posted on: September 20-2016 | By : Mallika Kamat | In: Business Agility,Software Development | 1 Comment

The IT industry is the most evolving industry across the world. Continuous innovation and transformation of IT keeps business across the world running. However, transformations are uncomforting, they involve investment of time, effort and capital. To make these transformations faster and efficient—in terms of cost and effort—it is imperative to undergo a major overhaul across the organization.

  When I say Agile does it ring the bell? Agile has become a buzzword in the IT industry. It is not just a software development methodology, it is the beginning of change in the organization structure and change in mindset. Organizations are rapidly transforming to agile from the traditional waterfall methodology.

Mallika Kamat

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Mallika Kamat
Mallika has over 19 years of experience in Delivery Management, majority of which is in the BNFS...

Posted on: March 21-2016 | By : Swati Phalke | In: Analytics,Big Data,Business Agility,Digital Skills,Digital Solutions,Enterprise Technology,Leadership | No Comments
For many years in the IT services business, there was a reasonable amount of demarcation in project execution using technology skills such as Mainframes, Client Server, Data Warehousing, Business Intelligence, and ERP. Projects were getting executed in silos for every Line of Business (LoB) within an enterprise. However in today’s digital world, there has been a huge disruption of the business model. Boundaries within the businesses are getting blur. For instance, retailers are entering into banking space to enable quick lending, sports companies are entering into consumer wellness, and mobile companies are entering into payments. Enterprises have restructured themselves to capitalize on the synergies within various lines of businesses. Hence, many digital projects need multiple technically-skilled professionals to join hands to deliver these business driven projects.

Swati Phalke

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Swati Phalke
Swati Phalke is Practice Director, Digital One at Syntel. She has over 19 years of technical and...

Posted on: February 26-2016 | By : Visukumar Gopal | In: Business Agility,CxO Innovation,Enterprise Technology,Innovation,Intelligent Business,Leadership,Managing Business Risks,Project Management | 2 Comments
An organization’s operational efficiency is largely dependent on how well it manages different projects. This calls for a well-defined project management approach that ensure projects achieving all predetermined goals with optimized allocation of resources. A Project Management Center of Excellence (PMCoE) enables organizations to have an enterprise level approach towards project management. PMCoE serves as a centralized body or function which has the autonomy to educate, energize and enrich people knowledge. This entity also has the excellence, best practices and expertise on project management.  
I will be focusing on some core concepts in the blog series, where I will highlight the importance of PMCoE in all industries.   Let us start by discussing the prerequisites of creating a PMCoE.   Project Management and Project Managers have never been more important to the accomplishment of corporate work scopes. An increased emphasis on performance, accountability, and cost-effectiveness is driving industries to reassess work scope planning and execution. Organizations are using Project management as ‘the tool’ for effective streamlining. This change, however, requires planning. No longer can workforce size, resources, training, or experience alone help organizations to achieve their goals. Accomplishment begins with judicious alignment of resources, a shift in corporate culture, and with a committed management team. It is a journey to excellence.   Cultural shift towards Project Management has been on going. To achieve a more complete transition, it is important to empower resources at every levels of the management. Involving all levels of management immediately sends the message of total commitment. Continued work toward institutionalizing the process also strengthens this effort. Pushing change requires wide spread, committed involvement. It keeps things moving.   Project management is one of the critical levers for organizational success. Today, organizations which excel in delivering their business are often at a higher degree of project management maturity than others that have not progressed in the path of successful project management implementation.   Sometime there is a lot of doubt over adoption of either a top-down or bottom-up approach for implementing new processes and culture. The organization’s culture has to support transformation at all levels. The leadership team is the key driver of enhancements needed by the organization. They authorize implementation efforts, exemplify practices, and provide support, while the operations teams have to have the buy-in necessary for the actual implementation of the project. Cooperation between the leadership team and operations team is essential to ensure the level of excellence expected by implementing project management principles.   In the next blog, I will be covering Characteristics of a successful PMCoE. Stay tuned.
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Visukumar Gopal
Visukumar Gopal is Practice Head, LEAN & Knowledge Management at Syntel. He has over 20 years...

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.

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...


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