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Posted on: August 23-2018 | By : Gauri Deshmukh | In: Clinical data management,Industries,Life Sciences,Pharmaceuticals and Biotech,SEND Services | 1 Comment

The pharmaceutical industry is undergoing a huge transformation. The traditional ways of clinical research will soon be a thing of the past, with disruptive technologies like machine learning (ML), artificial intelligence (AI), natural language processing (NLP) and robotic process automation (RPA) moving from niche positions to sweep across the pre-clinical and clinical research value chains


With new FDA requirements that took effect in December, 2016, you must be able to receive and submit non-clinical toxicology study data in the SEND format. The new SEND standards have a major impact on the industry, as they are now binding for all sponsors submitting non-clinical data to the FDA — re-structuring the way non-clinical data is collected and submitted.


Long-running legacy processes and a lack of standards have led to inconsistent data standards that differ from company to company. Moreover, there may be inconsistency at many levels within a single organization, depending on the enforcement of these standards.


Deadlines


The major challenges that the industry is facing with SEND implementation are:

Lack of resources with deep SEND and study-specific expertise

  • Deep standards knowledge is required for trial design creation and Study Data Reviewer's Guide (SDRG) content analysis and authoring

Tools for viewing study data and cross-study analytics

  • Increasing need for data exploration
  • Deployment, integration, advanced visualization and support for the selected system(s)

Global harmonization of SEND processes after mergers & acquisitions

Time-consuming and costly manual data QA checks

  • Existing products do not provide certain automated data checks
  • Many companies are using older Laboratory Information Management Systems (LIMS), which do not support SEND-compliant data collection

Data merging issues

  • Use of multiple LIMS systems
  • Multiple source files from CROs, in-house labs, etc.

Implementing SEND standards requires deep knowledge and expertise in understanding, planning, implementing and submitting non-clinical data to regulatory bodies. Small errors complying with SEND standards may result in a rejection, making it imperative that your submissions are prepared by experienced and knowledgeable subject matter experts.

We are here to listen. At Syntel, we understand the core problem, and put our experience to work addressing this challenge with a two pronged approach.

  • Ready pool of SEND SMEs. Implementing SEND standards is a niche skill, and it can be difficult to identify and hire the right team members. Syntel has a comprehensive process to find the right talent for your organization, including a n extensive screening process, SEND-specific training, an ongoing competency building approach, and a robust knowledge management framework.
  • Quality assurance (QA): QA demands 100% adherence to SEND standards and processes, along with data consistency. We ensure that your SEND data is consistent with the original LIMS data resource, and conforms to the FDA’s implementation of the CDISC standard.

Syntel offers a full range of SEND operational and data management services, with a pool of trained, talented team members ready to deliver high-quality service based on SEND and QA processes, established information security controls, and a scalable model ready to help you build a world-class SEND organization.


If you are ready to put your SEND compliance initiatives on the right track, you need to talk to one of our experts today and learn how Syntel can deliver the mix of skills and quality that you’ve been looking for.


Contact us at Syntel_lifesciences@syntelinc.com today.

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Gauri Deshmukh
Gauri Deshmukh is a Senior Consultant – Life Sciences at Syntel, providing Domain Solutions to...

 
Posted on: March 26-2018 | By : Sourav Gupta | In: Industries,Life Sciences | No Comments

The journey so far


Year 2017 was a learning phase for the Medical Device industry. With the official launch of the European Medical Device Regulations (EU MDR 2017/745) and European In-Vitro Diagnostic Regulations (EU IVDR 2017/746), many medical device and in-vitro diagnostic companies faced uncertainty and confusion over the new requirements, as well as risks and challenges to their business.


With few exceptions, I have seen most large manufacturers establish a program management (PMO) team and roping in top management consulting companies to help determine the impact on their business and revenues. Small and mid-size companies are working with regulatory consultants to understand the new requirements.


The second half of the last year was mostly spent on awareness sessions, workshops, gap assessment pilots and budget planning. I have spoken to many program directors to understand their strategy, budget and plan for the next two to three years, and led or participated in many knowledge sessions and workgroups. I have learned a great deal so far, and hope to share some of that with you today.


Key Lessons


  1. Simplify program management by creating a 360° view dashboard for each product family. This dashboard should include parameters like revenue, markets, risks, technical files, labels/IFUs, authorized representative, notified body, manufacturing sites, economic operators, QMS, etc., along with your key stakeholders from various functions.

  2. Remove redundancy and organize technical files and design dossiers for each product family in a centralized repository.

  3. Digitize high-value legacy records and technical documents for gap assessment, inspection readiness and easy availability.

  4. Plan ahead for your organization-wide implementation or upgrade to QMS ISO EN 13485:2016, MEDDEV 2.7.1 rev.4, UDI, eIFU Website (Content Management Framework).

  5. Prioritize the remediation of technical files for products with high business impact and complexity.

  6. Evaluate and onboard service providers early in the program to improve the success rate and on-time completion.

  7. Build an agile platform that enables internal and external stakeholders to engage and collaborate on a day-to-day basis.

  8. Implement tools and accelerators to improve visibility, tracking, quality and productivity across workstream projects and your overall program.


Key Lessons


While the industry is waiting for the re-designation of the Notified Bodies, most manufacturers have completed the impact and gap assessment of key technical files and are currently planning for technical file remediation. Keep in mind that if you have a high volume of technical documents, or they are complex, in legacy formats, or not well-controlled or documented under the same product family, remediation will require much more advance planning.


Key considerations for technical file remediation


Planning
  • Create/ update SOPs

  • Prepare quality plans for technical files and design history files (DHF)

  • Plan cross-functional work streams for document remediation

  • Identify critical success factors, risks and challenges

  • Develop a detailed checklist to review technical files

Reformatting GHTF
Summary Technical
Documentation (STED)
  • Update formats (GHTF/SG1/N011:2008 for medical devices; GHTF/SG1/N063:2011 for in-vitro diagnostic devices) to align with the new requirements

  • Format documents into paginated and fully searchable PDF files

  • Devise a logical numbering for files (e.g. Part 1 of x, Part 2 of x… Part x of x)

  • Bookmark GHTF STED sections with clear document references

  • Write technical files in an official language of the member state where procedures are carried out, or the language accepted by the Notified Body. English is recommended for all audit-related documents.

  • Use digital signatures or scanned signature pages where signatures are required

  • Make the technical documentation a pointer document

General Safety
and Performance Requirements
Checklist
  • Update the Essential Requirement Checklist (ERC) and map to the new requirements

  • Mention relevant standards “State of the Art” assessments (fully or partially applied)

  • Provide reference to harmonized standards and justification if not applicable

  • Look for objective evidence to support conformity, linking and bookmarks to relevant documents

Declaration of Conformity
  • Ensure the product list in the technical documentation matches the DOC

  • Sign a new Declaration of Conformity


Conclusion


It requires extremely careful planning and monitoring of different workstreams to successfully remediate technical files. By identifying critical success factors, risks and challenges early on, your planning will be easier and the chances of a “first-time-right” remediation program improve dramatically. By setting-up a digital PMO dashboard, QC checklists, tools and accelerators, you can help ensure a much smoother transition to EU MDR/ IVDR compliance.


Author
Sourav Gupta

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Sourav Gupta
Sourav Gupta has 14+ years of experience supporting the Life Sciences industry in the clinical,...

 
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


Author
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 | 9 Comments

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

Author
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: 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.


Author
Subhajit_D

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

 
 

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