This blog discusses latest trends and the role technology plays in the life sciences industry. It focuses on Infosys life sciences services and solutions and how they can help accelerate business.

June 7, 2016

Its CLOUDY everywhere, VIRTUAL SPACE MONSOON has already arrived!!!

The enterprise technology arcade is facing a huge change. The evolution of enterprise cloud technology, ever changing customer requirements and the digitization of the office space means, that legacy software corporations are transforming their methodology to sustain their topmost position.

Cloud gives us wings of liberty to navigate and dream of not buying, not physically accessing the storage disk and yet loading and handling your business data at secured location away from workspace, thus changing the business ecosystem!!

For business it's not sufficient to have just one utility on cloud, they need end-to-end business practices arranged by unified integration across practices and data, supported by standards-based technology.

Oracle cloud is one such offering, Oracle's cloud underpinning lies in its Fusion applications, explicitly ERP. Generally HR and CRM were the early movers to the cloud, with finance lagging -- but that has started to change now.

The Oracle cloud engine has four distinct parts: SAAS (Software-as-a-Service), PAAS (Platform-as-a-Service), IAAS (Infrastructure-as-a-Service) and, most recently, and DAAS Data-as-a-Service.

There is no disbelief that companies have to migrate to cloud for better organizational purpose. Oracle as a customer centric enterprise has also joined in that ocean offering services through cloud which will focus at the end to end solution rather than only on tools.


Continue reading "Its CLOUDY everywhere, VIRTUAL SPACE MONSOON has already arrived!!!" »

May 3, 2016

Project Management Methodologies

Project Management Methodologies

The blog is first in the series and will cover the very basic concept which help people to understand the Project and Methodologies better. In this blog I will be covering only few basic definition.

Project: "Anything which will be completed in limited time and result in some product and service" is one of the simplest definition I can remember.

Project can be subdivided in Phases

  • Justify

  • Initiate

  • Plan

  • Analysis

  • Design

  • Execute

  • Monitor and Control

  • Closed

Project Methodologies: The way project will be manage.


Plan Driven: As name suggest Planning is one of the important criteria. Everything is planned in details upfront and tracked later in the project. Change in the project is not preferred and are expensive. Ideal where complete scope is available.

Change Driven: Follow the iterative and incremental approach and only high level planning is done which will be sufficient enough for initial cost and time. Project Scope is develop with each iteration. Change is consider as good and last minute change is possible without increasing the cost much.

From : Manish Kumar

Continue reading "Project Management Methodologies" »

November 18, 2015

Predictive approach to 'Quality' in clinical trials



  Authors:  Deepak P.N., AVP - Principal Technology Architect; Pooja Durgad, Senior Associate Consultant; Renuka Natarajan, Senior Associate Consultant


Quality is not an act. It is a habit ~ Aristotle

A recent engagement with the clinical trials quality team of one of the top 10 pharmaceutical companies, located in North America, gave more insights to the way sponsors handle and manage the risks throughout the lifecycle of a typical clinical trial. Quality Risk management or QRM is the process of proactively identifying risks, prioritizing the risks identified and coming up with a mitigation plan to reduce the errors that matter for the success of the clinical trial. QRM is a collaborative effort between different stakeholders involved in the clinical trial and happens in parallel with protocol development. QRM, starts with protocol definition, spans through study conduct till database lock. Quality is an extremely important aspect of a clinical trial, especially given the fact that it impacts patient safety. It is important for trial sponsors to have a robust risk management mechanism in place to ensure that patient safety is not compromised. A proactive approach in identifying risks in a clinical trial would help the sponsors to put in place an effective risk mitigation plan and avoid fatalities, budget overruns, major adverse events, etc. attributable to lack of oversight.

Traditional QRM in clinical trials focused mainly on site visits, in-situ source data verification, source data review and audits conducted during and after a trial. However Clinical Trials Transformation Initiative (CTTI) encourages the use of Quality by Design (QbD) in 'Risk Based Monitoring' (RBM) of clinical trials. Quality by design has been successfully executed in the field of manufacturing, including pharmaceutical manufacturing, but has still not been fully translated in the clinical trial space as it is 'expert driven' rather than 'process driven'.  There are 4 elements to QbD, Plan, Do, Check and Act.



















Most pharmaceutical majors have established QRM processes in place to identify risks and come up with the mitigation plans. Our viewpoint is that they can take a more proactive approach and manage the risks in a better way to prevent/ reduce their occurrences. Pharmaceutical companies have huge repositories of past trials, both successful and unsuccessful ones and with the help of this vast repository, predictive statistical models based approach could be adopted to identify and quantify the risks early in the game. Based on the risk predicted for a study, the sponsor/ study team could come up with the appropriate mitigation plan which can be used in risk based monitoring. Predictive approaches have been used successfully in retail industry to enhance customer experience.

As a first step towards developing the model, Key Risk Indicators (KRIs) need to be identified. Some of the risk indicators could be protocol deviations, amendments to the protocol, quality issues, budget overrun issues, etc. The next step would be to identify the important study attributes that might impact the risk indicators. Examples of study attributes include, therapeutic area, study phase, statistical design, the number of subjects involved in a trial, etc. This would then be followed by model building, using appropriate statistical and machine learning algorithms, which would identify the patterns in the study attributes that lead to the behavior of risk parameters. The final step would be to use the models to predict the risk of a study. The predicted risk of a study can be categorized into different classes, namely, high, medium, low using color codes. This would help the sponsors in proactively coming up with a better risk mitigation plan for any trial in the future. This can be employed on an ongoing basis.


Infosys believes that statistics based predictive approach could very well be applied and adopted in clinical trials for better patient safety, quality of trials. Infosys, with its vast experience in ETL and data analytics space, would be an ideal partner to sponsors of clinical trials in aiding their proactive risk management process of clinical trials. Predictive analytics combined with RBM will have a very high potential to transform the way clinical trials are carried out.



November 16, 2015

Medical Camp - Data Integration for better Healthcare



It was March 2010 when RAHAT camp organized in Tribal district Mandla of MP treated 50000+patients for various ailments in 7 days. Camp was listed in Guinness book of world records. I was lucky to be part of such a mega camp as dentist, we witnessed various dental and oral diseases and a rear disease Noma(cancrum oris) whose reported cases in world are very few . In this camp huge amount of data was generated related to treatment modalities undertaken, medicines used and also disease pattern prevailing.

To my dismay this data was not converted into useful information which could be used in future to combat various endemic diseases, research and also I found lack of integration of various medical camp data which could be of immense help to healthcare industry.

I have noticed that to provide basic and also secondary healthcare, medical camps are organized by various organizations like WHO, UNESCO, Governments, and NGOS all round the world. Along with healthcare services these camps also generate data about diseases, medicine, procedure followed, patients and treatment options.

This data can be converted into information important for pharmaceutical industry, healthcare professional and govt. The data can be used as weapon to fight with various existing diseases, help develop new medicines and also identify emerging disease trends and identify new diseases.

Medical camp data is huge data which is unorganized and not integrated, making it difficult to use information for any good. This provides IT industry opportunity to develop systems that lead to proper utilization of all the data that is being generated and provide proper structural and functional data as required by the end user in order to draw complete benefits from these camps report.



Where is the Problem

Paper based reporting of camp is difficult to handle and information cannot be shared with other organizations when needed. Maintaining this paper based data is another problem.

Medical camps are organized in various location in the world, no single portal for camp registration, No standard way to report camp that is no template available, difficult data entry, data is not analyzed to draw useful conclusions, no integration of data from different medical camps, rural areas of various countries don't have basic facilities for camp to be reported, technical challenges in almost every step to make camp reporting feasible and organized.

Data from various medical camp is missed, this data can be used by various organizations according to the need.


Possible Solution:

  1. Convert paper based system to IT based.
  2. Common registration forum for medical camp treating more than 1000 patients.

  3. Standard template for camp reporting.

  4. Listing of all patients ,doctors and other healthcare provider participating in camp.

  5. Details of medicinal products to be used in camp and its manufacturer and supplier.

  6. Analysis tools incorporated in software.

  7. Use of software like MedSaaS for reporting and patient data.

  8. E protocol should be followed.(login information).

  9. Integration of data from all over world and also region wise integration.

                                                Text Box: Prototype for Integration of data*&auth=LCA%2080be12f4d61817c19a2833d1ac22c11cd4c269bd-ts%3D1439799554


All data from all over world should be collected and analyzed to find out

  1. Rare diseases incidence can be found and reported easily.

  2. New treatment which was effective can be reported for further research.

  3. Any issues with current treatment and also with medicine supplied can be found.

  4. Trends of emerging disease can be identified.

  5. Region specific disease can be identified(endemic).

  6. Helpful in identifying gap in medicines.

  7. Direction for pharmaceutical companies Research and Development.

  8. Adverse events with any drug will get captured.

  9. Can be helpful in taking preventive measures before any disease turns epidemic

Other things need to be addressed:

  • Patient confidentiality

  • Basic knowledge of computer and software to the camp organizers and team.

  • Regulation to make it mandatory for registration of camp.


This can be helpful to organizations like WHO, UNESCO, Pharmaceutical companies looking for new opportunities in Research and Development, and also to the governments of several countries.

June 5, 2015

From what's now to what's next in life sciences

Where there's big data, there's both risk and reward. By improving clinical trials and drug development, and assessing the potential of genome data, the life sciences industry is embracing this exciting data opportunity. What lies ahead for this data-rich industry? Read our infographic below to find out.

Infosys Full Graphic.png

For more information, download our PoV

May 26, 2015

Tracking Implant Device or Equivalent from Mobile Device

One of my favorite quotations is by the 18th century American statesman Benjamin Franklin, who said that for everyone "nothing is certain ... except death and taxes." His witty take on the drudgery of having to pay taxes is as applicable now as when he first said it 250 years ago. But today I would add another item to the list of life's certainties: regulations.

We live in a regulated world. Everything you see and touch and sit on and ride in is regulated by some government agency ... somewhere. To be sure, regulations can be very helpful - consider how regulations banning lead in paint as an additive has saved the lives of countless millions of people. Or the seat belt. Or the regulation that a sulfuric smell be added to colorless, odorless natural gas so that people could smell potentially deadly leaks.  The list goes on and on.

Nowhere is this playing out more blatantly than in the medical device arena. Three days ago, I was speaking to my client and she mentioned - she is not able to wear a wrist watch measuring her pulse rate as this devise needs to be FDA approved. And so the mobile phone apps. Across the globe, country's regulatory bodies (For ex: Food & Drug Association (FDA) in USA) has come out with a stringent list of regulations governing usage of medical devices. These are the kinds of devices that allow physicians to, say, monitor your heartbeat remotely. Manufacturers must meet all the classification, tracking, management, and registration guidelines for the medical devices they bring to market.

The medical device market is hot right now and there are lots of rising stars in this space. Those companies that will succeed are those that can overcome not only the stiff competition but also the near debilitating regulations that the FDA has mandated. Mind you, speed and next generation technology are very important to become successful, so meeting the desired timeline is vital in this market. What hurts manufacturers of high-tech medical devices is that each player of the entire supply chain of devices in both the commercial and clinical worlds (manufacturers, distributors, hospitals, patients etc.) are working in a disintegrated manner. Doing so creates an environment that smacks of lack of ownership as well as integrity for required information. Eventually, this disintegration will have a significant impact on the patient's safety not to mention on the brand value for the device manufacturer.

Infosys has developed technological solutions for both clinical and commercial medical devices. In the clinical arena, for example, the proliferation of mobile devices and the Cloud environment that uses next generation technology points to a holistic view of having an integrated solution for the device tracking. With next generation technology, end users would get an experience like never before to perform their tasks effectively and efficiently. Their sense of ownership also rises when they work in a more "user intuitive" environment.

Therefore, Infosys has developed technology that makes odious government regulations quite palatable. We've accomplished this feat by instituting end-to-end device tracking across the supply chain within or outside of manufacturer location. We also leverage next generation technology to enable mobile device applications. Plus, our "user intuitive" interface simplifies usage for business users and thereby improves efficiency. Then there's the part that would make a frugal scientist of the Enlightenment like Ben Franklin perk up and take notice: A pay-as-you-go model is available with our Cloud offering. It's amazing how being fully compliant with FDA regulations is simple and seamless when data integration and synchronization are involved. A medical device manufacturer asked a question to us - how much will you charge us to onboard a clinical trial on your platform? A different set of clients, very different business model and exciting programs waiting for us.

March 10, 2015

Bottleneck of one technology makes way for another; Oracle AIA!

Ever wonder how same technology in different way eases our business process. With the little Novel information how technology integrates different sources of information there by giving us the desired "right information".

Question directly comes what it takes to have the "right information"?

Responding this query forces the organization to identify and apprehend what information is desired to fully support the business practices critical to the company's triumph.

The clog is not in developing new revolutionary technologies, as some might believe. Rather it's in finding "revolutionary deployment" processes that would move available technology into widespread different use.

This vision completely comes into line with what our experience is while working with this telematics client; we at INFOSYS didn't invent any technology. We just thought-out out how to deploy it in optimized way, ORACLE AIA.

Utmost priority for any business is to track the Revenue for any HITS OR MISSES and main challenge on this while working with this telematics client was to integrate order entry and billing consolidation to know which and how many billing accounts have been dropped and why? For these two contrasting sources ORDER ENTRY (CRM) and BILING (BRM) we used an ORALE AIA view, which was already available with client, to consolidate the data in warehouse, order entry and billing consolidation was of utmost important and was achieved there by eradicating the need of multiple iteration to track every load in BRM before final bill is processed for every customer there by saving lot of time and effort.

Once a business has established a "revolutionary" business model that works truly well, technology can then play a key protagonist to hasten that business model, that's what was done.

The rudimentary necessity is to grasp how business processes are followed in industry; a business can then comprehend how information technology can be used as an accelerator to dramatically enhance those business practices.


Quicker ROI on BI, everyone's dream!!!


The importance of critical Business Intelligence (BI) lies with the bottom lying fact that whatever good or bad it delivers as quickly as possible. The basic objective for every organization is "Pervasive BI" correct information to the correct person at the correct time.

What is the "Right" Technology?

The selection of a method is a critical business assessment. With the present scenario and changing trends, businesses need bigger and faster access to more information to make quick and right decisions. The question is they getting it? Despite enormous expenditure worth billions of dollars on data administration and business intelligence tools, the solution in many cases might be No. With business intelligence (BI) solutions, an efficient execution isn't just economically smart--it has become a competitive obligation. The information organizations are looking for to manage business is constantly changing. The sooner they get access, construe and segment that information; the stronger their competitive position.

Two key reasons for turning software into a shelfware are fear of inaccurate information at end user level and annoying technological difficulty. These and other technical snags can quickly dispatch an expensive software solution to "shelfware" grade in an organization.

To avoid such inacceptable, annoying results; A Winning Alternative: Transform existing reports into live, actionable data. We need to have effective right-time business intelligence. Effective indicates that the BI is used to enhance routine functioning business does, and right-time signifies that this optimization happens at intervals that matches corporate requirements.




March 9, 2015

Business information in hands, just a click away!


It is vital for organizations to implement new tools and new technology, Mobility was one of those processes which business has not only used but has also been effected in larger picture on how different organizations use this technology and plan their business model.

Continue reading "Business information in hands, just a click away!" »

October 17, 2014

Importance of LIMS Vendor Qualification

Laboratory Information Management Systems (LIMS) offers key features that support a modern laboratory's operation in regulated environments. LIMS can save vast amounts of time and dramatically improve productivity within the workplace. LIMS vendors are growing at fast due to expanding LIMS market. Before the Pharma manufacturer purchases the LIMS product, it is recommended to conduct an audit of the vendor. Post purchase it a good practice to conduct re-evaluation after 1-2 years to ensure their Quality Management System continues to be followed since they will be sending patches and updates of their product.

Making the wrong choice of the vendor can increase the total cost of deployment 2-3 times of the original estimates and can result in a failed project altogether. Most of the unsuccessful LIMS implementations are having root causes in and around inefficient budget planning, improper project management and improper Vendor selection for implementation. Consequences of improper vendor selection are as follows:

1.    Inaccessibility of basic source code required for customization:  Typically none of the LIMS products can be used as-is out of the box, they need some customizations and configurations.  The vendors share the Application Programming interface (API) which makes the configuration of the LIMS package difficult. It increases dependency on vendors for subsequent configurations / customizations.

2.    Integration with current IT landscape (ERP, CRM, SCM etc.): LIMS COTS products available in the market do not properly integrate/interfaces with other landscapes which create need for extensive customizations.

3.    Exponential increase in cost of Validation: Due to increase in customizations the validation requirements increase which exponentially increases cost, efforts and resource requirements for validation.

4.    Insufficient coverage of regulatory requirements: For regulated Pharmaceutical manufacturer, adherence to regulatory compliance to 21 CFR part 11, GxP, EUGMP annexure 11 etc. is mandatory which is overlooked by some of the LIMS Vendors. Later it is achieved with significant cost and effort.

5.    Inadequate quality documentation of SDLC and CSV: Vendors normally do not share the Functional Specifications/Software Design Specifications/User requirements specifications which mandates the Pharmaceutical Manufacturer to create their own specifications for validating the customizations in LIMS package implementation. This becomes a major bottleneck for functional testing as the package is not properly tested and validated before implementation.

6.    LIMS Vendor may not be available for upgrade or future support of LIMS in case of any customization or development requirement if financial credibility or future plans of vendor are not understood properly during Vendor selection.

7.    LIMS is implemented with less functionality which is not satisfying all User Requirements scope objectives of Pharmaceutical manufacturer.

8.    LIMS is adopted with superfluous functionalities just because those are available in LIMS package. 

9.    Schedule slippages due to improper project planning and resources from vendor side.

These issues can be avoided if the customer evaluates and assess all these points before purchasing the product from the vendor. The Pharma manufacture is responsible for any lapses in the regulatory requirements and is accountable to regulatory authorities. Thus vendor selection is as important as the technology selection and sufficient due diligence is warranted.

Important factors to be considered during vendor selection are: Financial credentials, Future product plans of vendor, Technology, Platform, Product demonstrations, Implementation cost and time, Validation strategy complying all applicable regulations, SDLC & CSV documentation, LIMS support quality, and the consultant credibility.

When selecting a LIMS Product, it is important to select preferred and reputed vendor whose LIMS package is 'best fit' for your requirements. Some of the key points checked during vendor qualification are as below:

1.    Business Process Evaluation:  BPE is used primarily to define the role of LIMS within the organization. User Requirements must be clearly specified, concise and well understood.

2.    Financial Evaluation process: This process should include viability studies having below criteria:

o  What is the state of financial health of the company supplying the products?

o  Will they be around in 2 years when you need to upgrade?

o What are the future plans for the company? Are they planning on shifting business strategies, rendering your purchase obsolete?

     It is important to consider such concerns when selecting a product to ensure that the companies' resources are spent wisely.

3.    Vendor Survey demonstration process: A selected vendor should be invited to demonstrate a product taking into account the specific requirements. This process aims to identify the most proficient supplier and also helps as information-gathering tool. It gives the customer ideas of what can be done and educates them in what cannot be done so that Pharmaceutical manufacturer can amalgamate and prepare single proposal. As customization is an expensive way of achieving a 'correct fit'. By this way, LIMS matches your criteria as far as possible with little need for customization.

4.    Vendor Validation Process: As part of the vendor audit, the customer should thoroughly assess the validation methodology of the vendor. It should also check their change management and release management process. This will give an assurance to the customer of the processes and regulations they follow to develop their products and whether they meet their criteria. Any observations or recommendations during this assessment should be closed through CAPA by the vendor before start of contract. This will also help the manufacturer in determining their validation strategy during implementation.

Infosys has developed a comprehensive checklist and guidelines based our experience to help our clients select the right vendor for their LIMS requirements. The guidelines comprises of control points which are derived from FDA and EMEA regulations and helps in successful LIMS implementation eliminating all consequences mentioned in earlier sections of this blog. At a high level our evaluation checklist and guidelines can be categorized into following sections:

·         Information Risk Management

·         Software Development Life Cycle Process

·         Computer System Validation Methodology

·         Change Management and Release Management

·         Incident and Problem Management

·         Data Retention and Destruction

·         Quality Assurance

·         Financial capabilities and Relevant Resource availability

·         End User Training strategy

·         Customer Base and Current Engagements

There are many LIMS COTS products available in market which have almost similar functionalities and have very little difference. Around 80% functionalities are same and vendor selection will depend on the 20% functionalities which differ from other vendors. The manufacturer should take the required time to make sure that a reputed vendor with good credibility and at the same time cost effective is selected to provide a solution that best "fits" his requirements. Infosys with its experienced pool of consultants can help you in this journey by helping you to select the right product and be your implementation and validation partner thus minimizing the miseries during LIMS integration.

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