BLOGS

Blogs
Abhijit Joshi

The Clinical Study Protocol: The Basics

If you are new to the clinical research industry, it’s important to know how clinical studies are developed and run. The basis for all such studies is the study protocol, about which this piece will provide a high-level overview.

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Salesforce
Vigneshwaran Shanmugam

The Plinth of Software Integration-In a Nutshell

Digital transformation strives to make the businesses accelerate their growth by empowering their employees, engaging their customers, optimising their operations, and transforming their product.

Software Integration, the mainstay of Digital transformation helps in bringing various systems together and blend the functionalities to solve the complex business processes and improves the efficiency and reliability.

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Blogs
Abhijit Joshi

Enabling your Remote Workforce

We thought of changing it up this week to share how our team is working with our customers during these unprecedented times.

With today’s capricious working culture, here are some practices we are implementing with our loyal customers:

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Clinical Trial Management System
Abhijit Joshi

Clinical Trials of the Future

The clinical research industry has been rapidly remodeled by the digital revolution.

This paradigm shift is exploding into a new way of drug development and clinical trials. A way where patient experience is at utmost precedence.

Revolving business models, services, and products around the patient is becoming the new normal.

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Clinical Trial Management System
Abhijit Joshi

How Clinical Trial Sponsors Can Help During the Spread of COVID-19

As the spread of COVID-19 has affected every industry, pharmaceutical and biotech companies are feeling the heat of it. In our last piece, we covered some of the issues the clinical trial industry, as a whole, was facing. With unexpected delays, over-flooded inboxes, and patient safety at risk, here are specific ways sponsors can and are alleviating the negative impact of the virus…

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Clinical Trial Management System
Abhijit Joshi

The Resilient CRO

Overnight, the spread of COVID-19 has disrupted seemingly every industry from airlines and restaurants, to manufacturing. As the clinical research industry races towards a cure, it too faces distinct challenges. With rapid changes in regulations, patient safety concerns, and other COVID-19 related pressures, how can

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Blogs
Abhijit Joshi

A Letter to Our Industry

Dear Clinical Research Industry,

In today’s unprecedented times, our industry is amidst all the attention.

With currently over 300 COVID-19 ongoing trials worldwide, everyone is playing their part in creating the first in-class vaccine for this virus.

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Clinical Trial Management System
Mythri Raghunandan

Protocol Amendments – Causes, Impact and Strategies

Protocol plays a central role in the efficient execution and completion of a clinical trial. Any change to the agreed protocol that affects the safety of subjects, scope and quality of study is considered unavoidable. These changes result in delays in Study timelines, lower patient retention rates, Site burdens, impending costs etc.. According

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Blogs
Mythri Raghunandan

Spreading smiles one step at a time !!!

World environment day was celebrated by Cloudbyz at the SeedBall Creation drive organized by Saytrees on Sunday, 9th June 2019.Our employees aka Nature lovers took time out of their weekend and gathered to support a cause, “SeedBall creation Drive” an easy and sustainable way of increasing the green cover.One lakh seed balls

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Blogs
Mythri Raghunandan

Five Key Challenges to Site Payments

Sites play a very critical role in Clinical Trials and it’s very important that they get paid in a timely manner for the services they render. However, numerous surveys have shown that sites participating in studies face huge challenges related to timely payments leading to low satisfaction scores by sites on Sponsors and CROs.

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Blogs
Dinesh Kashyap

Best Practices and Assumptions for Clinical trial Budgeting

Developing a new medication is a tedious process and costs of clinical research are constantly on the rise. These are the main reasons for the decreasing trend in the number of filings with the FDA.According to the U.S. Department of Health and Human Services (HHS), clinical trial procedure costs are the highest in the first three phases of the clinical study.

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Blogs
Dinesh Kashyap

5 Things to Consider to Choose the Right CTMS

A number of solutions are being built to manage day-to-day clinical trial activities. Most solution providers in the market claim to have a complete CTMS solution, however, not all solutions have end-to-end features. A checklist for systematic assessment of the available CTMS solutions prior to investment is essential.
Most importantly, CTMS will be used to manage sensitive medical data

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Safety and Pharmacovigilance
Mythri Raghunandan

Benefits of Risk-Based Monitoring in Clinical Trials

Monitoring of clinical trials is a critical activity required to be carried out during the entire lifecycle of the trial to validate that it is conducted as per the approved protocol. Monitoring should also uphold the GCP requirements to ensure the integrity of trial data, safety, and rights of subjects.Careful and frequent monitoring can ensure…

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Blogs
Mythri Raghunandan

Dynamic culture drives innovation

Culture is the way people treat each other, day-in and day-out, working as a team towards a common goal. These are not a list of hard rules to be followed but are the values to be implemented. The best company’s culture is where employees are released from stress and perform well at work.It’s difficult or…

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Clinical Trial Management System
Mythri Raghunandan

Verily’s Project Baseline is modernizing clinical trials

A number of solutions are being built to manage day-to-day clinical trial activities. Most solution providers in the market claim to have a complete CTMS solution, however, not all solutions have end-to-end features. A checklist for systematic assessment of the available CTMS solutions prior to investment is essential.
Most importantly, CTMS will be used to manage sensitive medical data

Read More »
Blogs
Mythri Raghunandan

Cloudbyz’s Positive Step Towards Green Earth

World environment day was celebrated by Cloudbyz at the SeedBall Creation drive organized by Saytrees on Sunday, 9th June 2019.Our employees aka Nature lovers took time out of their weekend and gathered to support a cause, “SeedBall creation Drive” an easy and sustainable way of increasing the green cover.One lakh seed balls were

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Clinical Trial Management System
Mythri Raghunandan

Artificial Intelligence – Critical Prerequisite of Clinical Trials

A vast majority of researchers and specialized tech startup companies have started investing in developing Big Data and Artificial Intelligence (AI) tools to serve the pharmaceutical and medical devices companies, which is believed to transform the clinical trial process. But what exactly is the main outcome of AI?The buzz around AI

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Blogs
Dinesh Kashyap

8 Key Challenges to Clinical Trial Budgeting

Bringing a new drug to the market is an expensive venture and can take up to 10 to 15 years from discovery to launch. Clinical trial costs are increasing and so is the complexity of managing it. According to the Tufts CSDD March 2019 Report, Sponsors are spending more on CROs for developing new medicines rather than their own internal

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Blogs
Mythri Raghunandan

Making Clinical Trials Patient Centric – Essential Best Practices

The modern jargons “patient centricity” and patient-centric trials” have been revolving around the industry in recent times. However, there is a difference between patient centricity and patient engagement, which has been misinterpreted and interchanged often.and interchanged often. While patient engagement refers to the

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Safety and Pharmacovigilance
Mythri Raghunandan

Five Ways to Avoid FDA Warning Letters through Automated CTMS Solution

The violations of regulatory compliance may lead to the issue of a Warning Letter FDA WARNING LETTER AND FDA FORM 483. Over the recent years, most of these warning letters are due to non-compliance or negligence in the audit trail documentation practices.The means no backdating records, which the agency has noted as a problem in the past.

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Clinical Trial Management System
Dinesh Kashyap

Plan the Clinical Trial Design – The Cloudbyz Way

Clinical trials are research investigations in which people volunteer to evaluate medical, surgical, or behavioral intervention. The trial confirms a new treatment, less side effects and helps to make a better life for people with a chronic health problem. The U.S. Food and Drug Administration(FDA) typically requires Phase I, II, and

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Clinical Trial Management System
Mythri Raghunandan

Virtual Trials – Benefits and Challenges

Virtual trials are otherwise called Siteless trials done partly or on the whole virtually. The mobile device or wearable sensors such as a phone, watch, or even glasses can be used to collect the medical data in the clinical research study. Patients are treated via Telemedicine and Medical devices. Healthcare providers can evaluate, diagnose

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Blogs
Dinesh Kashyap

Top 5 TMF, eTMF Challenges

The trial master file is a collection of all essential clinical documents that enable the conduct of the trial and quality of data produced which is to be stored, evaluated, and maintained.An electronic TMF is the digital repository of all documents, agreements, contracts that are maintained and archived after every trial closeout. The

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Blogs
Dinesh Kashyap

Top 4 challenges facing CIO’s and IT Leaders in 2019

The arrival of game-changing technologies like mobile apps, social media, cloud computing has brought forth a new standard in the operational & decision-making process for many businesses. The CIO’s and IT Leaders role continues to undergo a transformation that is driving business leaders closer to customer demands and

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Blogs
Mythri Raghunandan

Cloudbyz – Safety – Pharmacovigilance Solution

Pharmacovigilance is a continuous process of collection and analysis of data relating to the detection, assessment, understanding, and prevention of adverse events of medicines and medical devices. Pharmacovigilance is critical for the Healthcare industry for approval of new drugs and devices and to further promote

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Blogs
Mythri Raghunandan

Top 5 Challenges in Pharmacovigilance

Pharmacovigilance focuses on drug quality, medication errors and adverse drug reactions which impact the health care system by affecting a significant patient population. WHO defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any

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Blogs
Dinesh Kashyap

Solutions to improve Patient Enrollment and Retention in Clinical Trials

Clinical trials are essential for developing new treatments, to understand the efficiency and safety of the drugs to be used for treating Patients. People should be encouraged to participate in clinical trials as they are going to be a part of the innovation which in turn will help a huge population of suffering patients. In…

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Blogs
Dinesh Kashyap

Patient enrollment and retention challenges in Clinical trials

A successful clinical trial depends on effectively enrolling and retaining participants. As the study progresses from Phase 1 to Phase 3 the number of participants required increases.Research shows that 9 out of 10 trials would not meet enrollment goals in a stipulated time which results in delays in finding new and better medication…

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Blogs
Dinesh Kashyap

How Chatbots Can be Employed in Clinical Trials?

Healthcare industry as a whole is now looking to better engage with patients using bots, where, the patients care aspect is being automated. The impersonal nature of the bots has a benefit in various situations, wherein a real doctor is not needed. In many cases, patients are more transparent to these chatbots than they are…

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Blogs
Dinesh Kashyap

A Guide to Building a Project Prioritization Scoring Model

Portfolio management is about maximizing organizational value delivery through programs and projects. In order to maximize value delivery, the governance teams that approve work and prioritize projects need to share a common view of “value” in order to use a scoring model to select the most valuable work and assign the right resources to that…

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Blogs
Dinesh Kashyap

Know The Difference Between Work Intake Versus Stage-Gate

What is the difference between a work intake process and a Stage-Gate process? This is important to distinguish, especially for newer PMO’s that are setting up portfolio management processes.The work in-take process refers to the steps of developing a project proposal and bringing it to the governance board (or PMO) for a

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Blogs
Dinesh Kashyap

The Remedyforce Ecosystem Spotlight – Cloudbyz ITPM

A picture’s worth a thousand words, at least that’s how the saying goes. We at BMC Remedyforce are excited to share a fantastic picture showing the ever evolving Remedyforce Ecosystem ! The picture above shows all the great integrations that Remedyforce has with other complimentary products. We continue to add partners

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Blogs
Dinesh Kashyap

Prioritization Matrix

In a recent LinkedIn discussion, questions were asked about the short-comings of prioritization matrices. I would like to highlight the strengths and weaknesses of using such a tool for portfolio management. Firstly, a prioritization matrix differs from a more traditional scoring approach in that it offers a limited number of priority selections. The most simplistic…

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Blogs
Dinesh Kashyap

Benefits Realization Summary

The purpose of validating benefits is to ensure that real value has been delivered from projects post-implementation as well as increase value from future projects when shortfalls have been identified in present projects. Although the business case promises to deliver a certain amount of value (in most cases), few companies

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Blogs
Dinesh Kashyap

Pipeline Management-Stage Gates Part 2

Stage gates are a governance structure to evaluate, authorize, and monitor projects as they pass through the project lifecycle. In the last post, we looked at the first four reasons for establishing a stage gate process in the organization. In this post, we conclude with the last four reasons for establishing a decision gate process.

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Blogs
Dinesh Kashyap

Greater Value From Portfolio Management Systems

Enterprise repository (“single source of truth”)—having a single system that contains up-to-date and accurate project and portfolio data is valuable. Gone are the days of maintaining multiple versions of static Excel files that contain the current “authorized” list of projects. This value is magnified easier to access the system and the greater

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Blogs
Dinesh Kashyap

Pipeline Management-Stage Gates Part 1

Stage-Gates™ are a critical component of project selection. A winning portfolio must contain winning projects, therefore the project governance board must be able to discriminate between good projects and great projects.The decision gate process enables the project governance board to review these projects based on

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Blogs
Dinesh Kashyap

Be Sure To Use The Portfolio Data

Data represents a major facet of successfully implementing project portfolio management (PPM). In a previous post, I discussed how data drives the portfolio management engine and some of the key components for getting good data into the tool. Some important portfolio data types includes: financial data, resource data, schedule data, and benefits data. Leadership plays

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Blogs
Dinesh Kashyap

The Right Portfolio Data at the Right Time

From a very pragmatic point of view, getting the right data at the right time is at the heart of good project portfolio management. If the right data is not available for decision makers to use, the issue will be mediocre results at best. Portfolio management is about selecting the right projects, optimizing the portfolio…

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Blogs
Dinesh Kashyap

Tactical or Strategic PPM

Fundamentally, portfolio management is about strategic execution and maximizing value to the organization through important project investments. Through various processes, leadership teams can determine how well their project investments align to key strategic goals. Optimization techniques can further enhance the value of the portfolio, ensuring that organizations

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Blogs
Dinesh Kashyap

Portfolio Planning vs Strategic Planning

Too often, the modus operandi for many organizations is to receive requests and filter them through a stage-gate process in order to evaluate the merit of the request and select the right projects. If the project is selected, a project team is assembled and the project planning begins. There is nothing wrong with this process, in fact, it is an important

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Blogs
Dinesh Kashyap

FDA Chooses Box for Cloud Content Management

The U.S. Food and Drug Administration (FDA) has reportedly selected Box’s cloud content management platform to modernize its technical infrastructure and drive new ways to work in the cloud. With Box, the FDA is furthering its IT innovation strategy to digitize business processes and envision new ways to engage with the

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Blogs
Dinesh Kashyap

Project Pipeline Management

Too often, the modus operandi for many organizations is to receive requests and filter them through a stage-gate process in order to evaluate the merit of the request and select the right projects. If the project is selected, a project team is assembled and the project planning begins. There is nothing wrong with this process,…

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Blogs
Dinesh Kashyap

IT Business Management – Run IT As Business

IT Business Management is a framework and approach that brings together people, process and technology to enable organizations to manage IT with real-time visibility, agility and support change and innovation. ITBM improves visibility on cost and performance and helps CIO and IT leaders to make right decision at the right

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Application Portfolio Management
Blogs
Dinesh Kashyap

Key Metrics for Application Portfolio Management (APM)

Application Portfolio Management (APM) is a framework for managing applications in enterprise. APM provides an inventory of an organization’s software applications and software-based services as well as metrics showing the business benefits of each application.Metrics can provide information from various perspective such as business ,

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Blogs
Dinesh Kashyap

Be Careful Managing Project Dependencies

Managing project dependencies are an important part of portfolio planning as well as tactically managing project execution. Unknown dependencies represent a major portfolio risk and in complex environments, inadequate identification of project dependencies can derail projects or programs. Dependencies can be any

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Blogs
Dinesh Kashyap

Cloudbyz ITPM July 2017 Release Overview

The Timesheet functionality which is typically the one used by all users in an organization is revamped with a simple to use UI providing users the ability to enter time against three categories of activities viz., Project, Operations and Organizational. Users would also be able to copy the entries from previous week thus reducing the time it

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Blogs
Dinesh Kashyap

How to Measure Projects Success: Successful vs. Troubled vs. Failed Projects

I can’t say that I am a big fan of it, because it fails to incorporate the value (i.e. the project portfolio management) perspective into the model. Recently I came across the one I really liked – a model that considers both project management (PM) and project portfolio management (PPM) sides proposed by Harold Kerzner,My view of a successful

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Blogs
Dinesh Kashyap

Project Portfolio Management – The Role of the PMO

The first role of the PMO is to act as a filtration mechanism for all the incoming project proposals. It is very important to point out that project management office should not have a mandate to overturn or reject project requests. Its role is to accept the business cases, review them and whenever possible to point…

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Blogs
Dinesh Kashyap

The Value of Time Tracking

What is the real value in tracking time for project and non-project work? The fact is collecting accurate time measurements across an entire organization can be time consuming and potentially expensive. Collecting time for the sake of collecting time is a huge waste of good organizational energy. I have compiled a list of six reasons

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Blogs
Dinesh Kashyap

Benefits of Social Collaboration

Innovation is a hot topic in business right now with an ever growing need for companies to deliver better products and services. A key ingredient for fostering innovation is enterprise collaboration. Until a few years ago, collaboration was often limited to smaller teams, but this could introduce a higher risk of duplicative efforts

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Blogs
Dinesh Kashyap

Five Uses of a Prioritization Scoring Model

Project prioritization is one of the most common topics in portfolio management literature. Within the context of project prioritization is the matter of scoring models because scoring models are the most widely used approach to prioritize projects. Although there are a lot of opinions on the effectiveness of common scoring models,

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Blogs
Dinesh Kashyap

The Purpose and Goal of Prioritization

Prioritization is about focus—where to assign resources and when to start the work. It is not about scoring methods and ranking mechanisms. Without defining project priorities, it is difficult to effectively distribute personnel to carry out the highest valued projects. Project priorities enable management to assign their employees to the most

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Blogs
Dinesh Kashyap

Strengthen Talent Management With PPM

When people refer to the “war for talent” many discussions center on talent acquisition and try to answer the question “how do we hire the best people?” Although talent acquisition is important, talent development and retention are also very important (you want to keep those great people you hired, correct?).

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Blogs
Dinesh Kashyap

Seven Steps to a Successful Project Portfolio Management Implementation

Considering the number of times I had to answer this inquiry in the last-four or five years, I decided that it might be a good idea to sum-up at-least the high-level steps required to implement PPM at any given company. And here should be a serious-commitment from the senior executives the company to install systematic,

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Blogs
Dinesh Kashyap

PMO as a Service

Program and Project delivery in IT is becoming increasingly complex and challenging with the dispersion of project teams across geographies, multiple vendors, dynamic changes in scope, and stakeholder expectations of faster delivery at lower budgets. PMO function plays a crucial role in managing this complexity and overcoming the challenges.

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Blogs
Dinesh Kashyap

Top 10 Project-Risks and What to Do About Them

by Jamal Moustafaev, MBA, PMP – president and founder of Thinktank Consulting Here is my favourite definition of risk: Risk is a bad thing that can happen on your project, but you are not entirely sure it will Below you will find a tables 1 and 2 with ten most-common risks and ways to address them both-early(highly…

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Blogs
Dinesh Kashyap

Communicate Portfolio Value

By Tim Washington, Point B I recently finished a project helping a CPG organization within a large retail company implement a product portfolio management process. The company

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Blogs
Mythri Raghunandan

Cloudbyz, xLM Partner to Deliver “continuously” validated Cloudbyz CTMS

This partnership combines Cloudbyz’s eClinical Trial Apps with xLM’s Continuous Validation service that enables delivery of “validated” apps. xLM, LLC, the first managed service provider for delivering continuously validated cloud apps, today announced a partnership with Cloudbyz, a provider of eClinical apps built on Force.com.

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Blogs
Dinesh Kashyap

Portfolio Optimization—Data and Constraints

In our hyper-accelerated business world, data analysis and data visualization are exceptionally important. In the realm of project portfolio management (PPM) and PMO’s, organizations need robust data analysis to strengthen decision making and improve strategic execution. The key is to have the right processes in place to collect the right data and ensure

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Blogs
Dinesh Kashyap

How to Prioritize Project Features and Explain the Process to the Stakeholders

When the Requirements Specifications is complete, the project manager (or the business analyst) must inspect the document with all the stakeholders in order to (along with other very important things) prioritize all of the project features and/or requirements. Project features have to be prioritized for the following reasons:Prioritization eliminates unnecessary, frivolous scope items added

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Blogs
Dinesh Kashyap

Integrate IT Service Management and IT Portfolio Management

The value of IT Service Management (ITSM) is clear: thousands of organizations, including 85% of the Fortune 500, are successfully using ITSM to improve efficiency, effectiveness, control, and insight while improving customer experience and satisfaction. Barely on the radar even a decade ago, the idea of leveraging best practices in the enterprise IT

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Blogs
Dinesh Kashyap

IT and HR Together Enabling Success

At first glance, Information Technology and Human Resources have little in common: IT focuses on the “hard” stuff – data, applications, infrastructure – while HR tends to focus on the “soft” stuff – people, skills, talent. With different cultures, perspectives, and ways of working, IT and HR appear to have little in common. Yet at…

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Blogs
Dinesh Kashyap

Integrated IT Portfolio Management In Digital Age

As digital transformation reshaping the enterprises across the industries, IT leaders recognize the need to innovate more, manage uncertainty better and establish more agility. However, they have to do this while simultaneously running the business and hitting regular performance goals, which is where both traditional and agile capabilities

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Blogs
Dinesh Kashyap

The App Gap and Shadow IT

Portfolio management is about maximizing organizational value delivery through programs and projects. In order to maximize value delivery, the governance teams that approve work and prioritize projects need to share a common view of “value” in order to use a scoring model to select the most valuable

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Blogs
Dinesh Kashyap

Portfolio Reports – Portfolio Bubble Charts

This is the third post in a series on portfolio management reports. In the first post, we reviewed introductory portfolio management reports that convey the basic dimensions of the portfolio. In the second report we reviewed treemaps and advanced pareto charts that can help identify outlier projects worthy of more scrutiny. In this post we…

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Blogs
Dinesh Kashyap

Project Portfolio Model

The next company to be discussed in our ongoing project portfolio management series is a rail transport engineering company that has encountered several challenges in the past several years. The organization has been reporting heavy losses from its operations for the past decade with no sign of potential improvement.The analysis of the company’s operations has shown…

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