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Posted on: August 16-2018 | By : Shailesh Gadhave | In: Digital Age,Digital Solutions,Life Sciences,Pharmaceuticals and Biotech | No Comments

The life sciences industry today is undergoing a wave of disruption, with biopharmaceutical companies embracing potential new ways to deliver a value-based model over volume by developing specialty products in target segments.


This wave of change is due to the fact that science and business operations are becoming increasingly complex, competitive and global — with companies attempting to make a comprehensive impact in this highly competitive marketplace. With increasingly complex development processes and soaring research and development (R&D) investments, stakeholders (business, end users, investigators, etc.) are looking for a more robust, reliable and reproducible approach to bringing personalized products to the market.


Even though the digital technology exists today to optimize the entire R&D value chain, adoption is low — especially in clinical trials segment — because of factors like complexity, resource-intensiveness, changing regulatory dynamics and lengthy implementations. However, while these factors may seem like an argument against implementation, the rewards are worth the effort.


As industry leaders move towards adopting personalized medicine and a patient-centric approach, it is increasingly important for clinical development enterprises to gain access to the growing volumes of patient historical data, real-world evidence, genomic profiles and emerging research to meet sponsor expectations. Harnessing this data can help investigators get a 360º view of patient performance and demonstrate the true value of new treatments to key stakeholders for effective market access.


Digital technologies can transform how companies approach clinical trial management, by enabling them to access a wealth of information from different data sources, improve patient enrollment and trial experience, capture real-time data insights and improve the quality of data collected during trials. Collectively, this can help achieve the following clinical objectives:


  • Expedite patient enrollment and retention by mining unstructured patient health data and identifying the right patient-trial match

  • Enhance patient trial experience to transform subject onboarding, trial understanding and helping set realistic expectations

  • Build an integrated trial management platform that can capture, integrate and analyze complex data during trials

  • Manage / regulate multiple sites and trace performance using advanced analytics and visualizations, enabling early intervention or shutdown of non-performing sites

  • Effectively manage stakeholder expectations and performance delivery


In our opinion, adopting digital technologies is an imperative strategy for clinical development enterprises. Emerging technologies like artificial intelligence, machine learning and advanced analytics are empowering CROs to reduce cost, integrate trial management, establish a tighter control, enable smart manual intervention, deliver quality outcomes and reproduce results in multiple scenarios.


In upcoming posts, we will further explore this promising synergy between technology and science to advance innovation in medicine. Stay tuned!



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Shailesh Gadhave
Shailesh is a post-graduate candidate in Marketing-Life Sciences with passion for developing novel...

 
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: 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.

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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: December 12-2015 | By : Swati Phalke | In: Big Data,Cloud,Digital Solutions,Innovation,Mobility,Software Development | 1 Comment
As we entered the 21st century, the Information Technology industry was celebrating the success of Y2K and then got overwhelmed with Dotcom. Enterprises started to automate their processes using Web 1.0, and a number of Dotcom start-ups came into existence. Later, due to financial crisis only select few survived the pressure.

Author
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...

 
 

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