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Posted on: January 03-2018 | By : Rahul Ganar | In: Industries,Life Sciences,Pharmaceuticals and Biotech,TMF Management | No Comments

TMF practices have matured considerably, and are now recognized as a critical step in the drug development cycle. However, a number of challenges persist. One key issue facing the entire life sciences industry is the fact that sponsors, CROs and affiliates often maintain multiple TMF instances — which increases the manual work required and creates redundant practices and processes that increase the complexity of TMF management.


Other challenges that the Life Sciences industry faces today include:


  • CRO coordination, to ensure the right documents are available during audits and inspections.In many cases, CROs manage their TMF system and sponsors manage their own. This makes it difficult to ensure the accuracy, completeness and timeliness of documents, as there is no clear ownership or accountability of TMF documents.
  • Governance, for better sponsor oversight and governance of CROs, affiliates and other functional service providers for TMF management. Document submission timeline is also an issue, as documents are often pushed on to the TMF system at the time of inspection, and not on a regular basis
  • Quality by Design, TMF operations for many life sciences organizations are combined with clinical trials and regulatory document management functions. This leads to quality issues, because there is not an exclusive focus on TMF documentation, which needs a more thorough and focused approach.

Is your organization facing any of these challenges? Do you need help providing answers in advance of an audit or inspection? If so, we want to hear from you, learn about your challenges, and explore how we can work together to ensure that your organization is always audit and inspection ready.


To start the conversation, reply or comment below, or reach out to us at LifeSciences@syntelinc.com


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Rahul Ganar

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Rahul Ganar
Rahul Ganar, Senior Business Analyst, Life Sciences, Syntel has more than 10 years of domain and IT...

 
Posted on: December 01-2017 | By : Subhajit_D | In: Artificial Intelligence,Industries,Project Management | 1 Comment

The 2001 French romantic comedy Amelie told the story of a shy waitress who decides to change the lives of those around her for the better, while struggling with her own isolation.

The painting below captures one of the 222 moods that the main character depicted in the movie. It was drawn by an aspiring artist that claims the goal of the project was, “To be taken seriously — one day — as a creative artist in my own right.”

Before we continue, see if you can answer the following two questions:

  1. Who is the painter?

  2. Why are we talking about a movie and a painting when this article is supposed to be about merchandizing and AI?

To answer the first question, the name of the painter is The Painting Fool, an AI enabled computer program that skillfully simulates the painting process. However, the answer to the second question is much more interesting.

Merchandising and the role of merchandiser has always been about creating a relationship between a brand and a consumer, to the extent that it evokes a strong emotion and a behavior. Merchandisers are the fuel that drives a store’s vision for inventory, tells a compelling story that influences customer desires, helps them relate that feeling to a product line, and triggers the sale.


While there are more or less “scientific” merchandising principles, formulas and theories, the knowledge, experience and intuition of the retailer brings something indispensable to the table – the “art” of merchandising. This brings us squarely back to the answer to question #2 above.

At Syntel, we always keep an eye on the horizon, and have been steadily investing in developing an ecosystem where designers, merchandisers and buyers will leverage AI to predict what customers want before they even know themselves.

We believe that the future of Merchandising will capitalize on the inherent creativity of the human mind, backed by AI-driven creative algorithms. Clearly, merchandising design and planning requires a lot of creativity and prediction to succeed, and AI and ML will help lead the path forward.

As a trusted technology partner, Syntel can help our clients harness AI and ML to progress in their Merchandising journey by focusing on:

  • Customer Experience AI: Assemble and recombine a series of components and thousands of potential configurations to identify factors that drive maximum impact and saleshe painter?

  • Managing Variations through Automation: Define and manage automation algorithms and large data sets that use continual iterative A/B testing to pick “winners” for customer latent needs

  • Mental and Data Models to Recommendation Engines: Use a data-driven approach to build inputs that run the recommendation engines

  • Capturing Nuanced Customer Triggers and Signals: Capture and identify the customer responses of and discover insights that define discovery of next generation traits

If the pundits are right and AI truly does take off as predicted, this technology will have a role to play in virtually every aspect of our lives. If the work of The Painting Fool is any indication, even creative fields like Merchandising may experience a “bot” explosion. To capitalize on this wave of innovation, you need a partner that is well-versed in the latest technology but has a deeply-rooted understanding of your business.

To find out how Syntel can help, please reach out to your Syntel Client Partner or learn more about our AI and Machine Learning solutions online at www.syntelinc.com

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Subhajit_D

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A graduate from IIM Calcutta with 10 years’ experience in the industry, Subhajit Dutta is a...

 
Posted on: November 27-2017 | By : Subhajit_D | In: Analytics,Big Data,Cloud,Industries,Retail | No Comments

I follow the startup world very closely, as it keeps the maverick technology enthusiast alive in me — and never fails to dish out an interesting story. I can honestly say that I have found this to be the easiest way to remain informed and relevant in today’s fast-paced tech world. Perhaps it is also a selfish attempt to avoid becoming a "technosaur".


Thus, it came as no surprise when I read about a European online fashion and lifestyle retail startup called Lesara that had increased their sales by 175% last year. Their product range has grown to more than 100,000 items, and they recently expanded to serve markets in Sweden, Denmark and Spain. All this with just 300 people on the payroll.


With this kind of growth so early on, I knew that this retailer was actually doing something technologically disruptive.


Founded in 2013, the company has tried to solve a problem that fashion retailers have long faced: how to bring products from the catwalks to the catalogue as quickly and as accurately as possible. Lesara’s approach uses cloud data analytics and cloud-based AI to make statistically-based decisions about what clothes it should produce and sell. It pulls data from various online sources, including e-retailers, search engines and social media to help it make real-time, informed business choices about which products they need to create.


“This analysis removes the guesswork about what will sell and which styles will flop on the shelves. We don’t just know which new styles are popular, we can also identify retro trends that are making comebacks, which styles are on the way out, and that helps us to precisely manage our production.”


Roman Kirsch CEO, Lesara

What amazed me most about the story was not simply how they could turn a product from idea to market in just 10 days, but also how technology was envisioned and leveraged to manufacture a solution to this problem. As a tech enthusiast, I am thrilled whenever groups of individuals break out of the “business-as-usual” mindset of technology as just a cost reduction lever or an enabler.


It’s exciting to see entrepreneurs recognize the transformative role that technology can play, and use it as a driver to envision a new and novel way of solving a problem.


The moment we stop thinking about cloud technology as an effective way to move expenditures from CapEx to OpEx, we embrace the future. Instead, let’s recognize cloud’s potential to create products, manage inventory, understand customers better, and sell more and better products. One we start thinking that way, “retail nirvana” will be within our grasp.


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Subhajit_D

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Subhajit_D
A graduate from IIM Calcutta with 10 years’ experience in the industry, Subhajit Dutta is a...

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

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

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...

 
 

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