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Posted on: July 17-2017 | By : Gauri Deshmukh | In: Industries | No Comments

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    Pharmaceutical companies are often among the largest and most complicated organizations in the private sector, which are constantly under close scrutiny and subject to complex regulation. Their business success depends on the timely and successful completion of clinical trials. Clinical trials generate incredibly complex data and unless there are efficient processes and modern technology in place, numerous problems can occur. Without the right processes and supporting technology, pharmaceutical companies can pursue a flawed trial or flawed compound for too long and fail to cut their losses. Even if the trial design is good and the compound is promising, the inability to collect, manage, analyze, and package the clinical data can produce long delays that cause costs to soar and keep the drug from hitting the market.


    A deeper look at each step of the drug development process reveals a recurring theme of missing, incomplete, or erroneous data that wastes time and resources and adds months or even years to the drug introduction process.


    It is imperative for pharma companies to master the key entities in clinical trial data for real time feedback on trial progress and patient compliance, reducing the overall elapsed time and cost of clinical trials.


    Current data issues in the pharma industry

    • Lack of consistency in creating unique identifiers for products, projects, studies, sites, investigators, and other key data across the company hampers project management and cross-functional communication and coordination


    • Insufficient enforcement of clinical study data standards significantly increases processing cost at multiple stages and compromises study quality – potentially placing patient safety and entire development projects at risk


    • Difficulty in locating documents in a timely manner, due to inaccurate or incomplete document metadata tags, poses (potentially critical) risks to regulatory submissions and inspections


    When is data considered to be of high quality?


    When the data:

    • Is accurate, current, consistent, complete, and relevant
    • Possesses integrity (e.g., unique identifiers, no duplicates, and parent-child records are properly linked)
    • Can be easily accessed across systems
    • Can be easily processed and analyzed for multiple uses
    • Retains all of the above, even as data volumes grow and new data sources and integrations are introduced


    How can this be achieved?


    A robust Master Data Management (MDM) Solution can help achieve all of the above by offering a customized solution in the near term, mid term, and long term, aligning to the strategic needs of the customer.


    Master data management has helped customers achieve great successes in other industries. It’s now time for the pharma industry to use this solution to achieve the below benefits:

    • Simplified business operations, standardized processes and better cross functional collaboration for study, site, product, project, investigator, and subject enterprise assets management
    • Single source of truth to publish these key entities to all the required stakeholders/systems across the enterprise
    • Facilitate connecting the dots to identify new business opportunities and facilitate strategic decision making by providing consistent, consolidated, standardized, enriched, accurate, and inter-related master data to reporting and analytical systems


    Summary


    The global digital disruption affects the pharmaceutical industry as much as any other industry. The companies that succeed will be the ones that best manage, use, and share data.


    Transformation, however, is not necessarily an immediate change. Especially in large companies, new processes and technologies will be implemented over time and potentially a large number of individual projects. Each project will need its own justification, delivering a measurable return on investment. Using MDM to deliver the master data needed for each project’s success accelerates RoI on each project by making it easy to rapidly find and reuse the data required for an individual project.


    MDM helps us by providing processes for how we collect, summarize, and cleanse our data to ensure consistency, and appropriate governance in the ongoing maintenance and use of this data.


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    Gauri Deshmukh
    Gauri is a domain Consultant for Clinical Data Management. She has more than 11 years of Domain...

     
    Posted on: July 11-2017 | By : Prashant Ranade | In: Industries | No Comments

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      Whether we are ready for it or not, the digital age is upon us. Not a day goes by without reading or hearing about some digital disruption in today’s global economy, as more companies build their business models on next-generation technology.


      While it has created new opportunities, digital also forces CEOs to understand how to effectively use technology in today’s fast-paced, on-demand world.


      To truly “go digital” requires seamless end-to-end technology integration, not just a swanky front-end app, because “anytime,” “anywhere,” and “always-on” are the true barometers of a digital enterprise.


      For the CEO, this poses a complex challenge: how to improve efficiency, agility and speed to market, reduce run-the-business costs and channel this savings into change-the-business efforts.


      Clearly, the central challenge of digital modernization is adapting to change, but at its core, digital is like any other technological innovation. Innovation can enable us to do something completely new, such as in the case of air travel, x-ray technology and television. In the digital age, this is exemplified by the payments industry. Anyone can now process credit cards, buy a coffee using just their phone, or even pay for items as they are placed in a shipping basket.


      Innovation can also enable us to do something more easily, more efficiently, or more elegantly. Examples from the past include more efficient travel via automobile or more convenient communication by mobile phone.


      In today’s travel industry, the core products and services — like reserving and purchasing airline tickets or rental cars — have not changed, but mobile technology has now enabled an easier, more convenient, and more elegant way to manage travel.


      The fundamental job of a CEO is to look at their business and decide the “what” and the “why” of the business and figure out how to create a differentiated offering. The CEO then needs to ask the question: Do I want to do something completely new, do I want to make my existing business more elegant or efficient, or strike a balance between the two?


      Once that is decided, it is time to engage your outsourcing partner.


      How Your Outsourcing Partner Can Help

      Here are some ways an outsourcing partner can help CEOs navigate the digital landscape:

      • Stay current on the latest technology

        Your company may operate an airline, issue credit cards, provide banking, investment or insurance services, or manufacture a product—and it’s the CEO’s job to focus on this core business. With the rapid pace of change in the digital age, it’s almost an impossible task for a CEO or their teams to stay current on numerous complex technologies. Moreover, digital technologies are constantly evolving, and the “latest and greatest” tech may not be mature enough for your business. Your outsourcing partner’s core business is technology. Let them do the research, training, and heavy lifting. They should explore how new technologies can benefit, damage, or otherwise affect your business.


        In the face of digital disruption, there may be a point where you need to make tough decisions on which systems to retain and manage, which to migrate to new platforms, and which need to be re-invented and modernized completely. A trusted and experienced partner can help walk you through this decision, and a strong ecosystem of partners can improve reliability and speed to market.


      • Provide the scale you need to support your business.

        The mantra today is lean and efficient, both for staffing as well as for skills. Hiring and training is expensive, so let your partner bear the risk and burden of keeping enough staff on hand to handle peaks and valleys in demand – it is their business. They should be able to provide recommendations to build human and computing architectures that can scale as you grow. Above all, be intellectually honest. Tell your partner where you want the business to take you, and ensure that their plan can scale for the long-term, not project by project. It’s best not to enter the discussion with preconceptions of “how big” or “how much” of any resource will be required. Experienced partners can employ strategies like managed services and automation to create scale where you thought there was a bottleneck.


      • Manage the cultural and communication aspects of technology projects.

        The challenges of managing complex projects over long distances and long time periods are well-documented. If you had to invent a process and methodology from scratch for every project, nothing would ever be finished. Be sure that your partner is well versed in the latest methodologies.


        As a CEO, you must clearly communicate the business needs, and let your partner recommend a suitable approach to achieve your goals. There are new development techniques like Distributed, Scaled, Offshore Agile or Ogile® can virtually erase geographic differences and bring teams from all across the globe together for a project.


      With nearly two decades of experience as a CEO as both a user and a provider of outsourcing services, here is what I have learned:

      • It’s easy to get drawn into the technical or operational aspects of any project. Stay focused on the end game, and be clear about the outcomes you hope to achieve, not the “nuts and bolts” of a project.
      • Know what aspects of your business are outsourced, but retain your overall ownership of the project and be sure it is aligned with your business strategy.
      • When engaging with any kind of outsourcing partner, step back from the details and identify the business challenges that you want to solve or overcome. Remember that ultimately, you are responsible for the “what” and the “why” of the project.
      • Communicate these goals early and often, and let your partner do what they are best at – the “how.”


      There are many reasons to outsource in the digital age–technological, operational, cultural–but the visionary CEO will take a close look at their business to understand how best to use digital disruption to their advantage. Whether it’s finding a new way of doing business or simply an easier, efficient, or more elegant way of running current processes, CEOs must stay true to their business, focus on their core competency and see the big picture. Everything else is just ones and zeroes.


      This article was originally published on The CEO Forum

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      Prashant Ranade
      Prashant Ranade is the Co-Chairman and former CEO of Syntel, a global provider of integrated IT and...

       
      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

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

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          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. (more…)

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          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...

           
           

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