Managing clinical trials in today’s landscape can be extremely challenging. Several roadblocks can come in the way of successful product development, starting from lack of transparency and visibility into trial costs to hindrance due to organizational and geographical boundaries, non-standardized processes to disparate systems, and so on.
Managing clinical trials in today’s landscape can be extremely challenging. Several roadblocks can come in the way of successful product development, starting from lack of transparency and visibility into trial costs to hindrance due to organizational and geographical boundaries, non-standardized processes to disparate systems, and so on.
A virtual clinical trial, also known as a decentralized clinical trial, is comparatively a new method of conducting clinical trials virtually. In a true sense, a virtual clinical trial has no physical interaction during the entire process. Technology plays a major role in a virtual clinical trial. Different patient-facing technologies like wearables, electronic monitoring apps, online social engagement platforms, etc. are used extensively during a remote clinical trial. The idea of a virtual clinical trial has been around for some time, however, it has never been a popular path for sponsors…
If you’ve been around the clinical research industry, the concept of obtaining electronic consent is probably familiar to you. Considering the current pandemic we are in, many sponsors, sites, and CROs are slowly turning towards an eConsent process. Here are some of the hot features that most organizations are currently looking for in their eConsent solution:
In this blog we will learn Salesforce flow and how it is similar to apex coding. Salesforce flow is a declarative way (Drag & Drop)
Co-authored by Dinesh Kashyap If you’ve been involved in a start-up of a clinical study, you’re probably aware of the challenges that come with patient
The whole world is working from home now and is going to do so throughout the year. We need to gear up for this situation
Open reports with a click of a button and dynamically pass parameters to report filters! Purpose: This blog will show you how to create dynamic
Healthcare Industry is the most sought after industry in today’s business world as it strives to improve the quality of life from all hard times.
Cloudbyz CTMS, the leading product in Clinical trials software sphere helps the CROs and clinical research specialists to manage their data in a mannerly way which improves the efficiency and reliability as it is flexible and highly compatible with the third-party systems.
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.
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.
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:
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.
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…
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
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.
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
Team Cloudbyz got together for the most fulfilling time spent on Nov 6th at Samarthanam Trust – an organization for the differently-abled located at HSR Layout, Bangalore. The officer on duty at the Trust was very warm and explained about the early days of the institution and the Himalayan strides they have made with the help and support of many philanthropic minds.
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.
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.
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
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…
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…
Verily, a subsidiary of Alphabet inc. and the sister company of Google Inc. has initiated Project Baseline, with the aim to leverage the collaboration of clinical research and clinical care providers to develop proactive healthcare tools and services. Verily is partnered with Pfizer, Sanofi, Novartis and Otsuka to explore the opportunities in cardiovascular disease, oncology, mental health, dermatology, and diabetes.
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
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
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
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
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.
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
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
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
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
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
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
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…
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…
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…
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…
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
Cloudbyz and BMC hosted a webinar on “Achieve real-time visibility on Enterprise IT with Cloudbyz ITPM and BMC Remedyforce” on 18th Jan 2018.
Cloudbyz ITPM solution helps organizations gain visibility, insight, and control across all work.
Cloudbyz ITPM solution helps organizations gain visibility, insight, and control across all work. The solution provide the tools to properly align resources, projects, and goals, optimizing
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
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…
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
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.
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
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
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
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…
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
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
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
Project pipeline management is an important component of project portfolio management (PPM) because it encompasses the work needed to “select the right projects”. Pipeline management
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
Houston, USA 20 Aug, 2017– AutomationEdge, one of the global leaders in providing IT Automation and Robotic Process Automation (RPA) solutions, announces its partnership with Cloudbyz, a leader in cloud based enterprise applications. The strategic partnership will enable both the leaders to serve their customers much better by
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 ,
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
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
Traditional Models There are a lot of rating models out there that attempt to define project success or failure. There is the traditional one: Success:
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…
One of the first steps to collecting the maximum possible number of proposals is to make the submission process simple. One of the tricks used by some of my clients was to publish the finalized version of the scoring model on the company Intranet that was accessible to all company employees. Another organization went as far as printing
Infographic – Pharmaceutical Industry – Project Portfolio Management Summary
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
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
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,
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
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?).
There are many different approaches to project prioritization, but the most popular ones are the financial method and the scoring model. In this posting let us
A question that I get asked fairly frequently during my consulting or training engagements sounds something like this: We have heard about this “project portfolio
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.
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
I recently finished a project helping a CPG organization within a large retail company implement a product portfolio management process. The company as a whole
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.
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
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
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
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…
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
What is the App Gap, beyond a fun expression? Today’s post looks at the issue of the APP GAP, an issue we touched on previously.
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…
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…
So, here is an example of a “back of the envelope” calculation of total project resources bucket at a company that has proven to be extremely robust.
Imagine that there are 250 employees working at the head office. It has been estimated via survey or questionnaires that approximately 30% of their time is spent on project work and 70% on business as usual, i.e. normal daily non-project tasks. Based on that information we can assess the size of the total project resource bucket at the company:
Is it any wonder that the vast majority of IT leaders have no idea what is in their organization’s Application Portfolio, how much it costs, and whether it actually supports business objectives?Today’s IT portfolio management landscape is littered by spreadsheets, sharepoints, emails, and single purpose, fragmented point tools that require error-prone manual consolidation
A recent report from Fujitsu and subsequent post from Derek du Preez at Diginomica are must reading for every CIO and IT leader. The sobering report indicates that IT and business leaders agree that digital transformation is critical for top line success and creating value for customers. Yet most organizations lack a clear strategy
Steven Hall of ISG – writing at CFO – has penned an excellent post “How Do You Know if IT Costs Too Much?” that very much reflects our thinking here at QuePro Advisors. Steven’s post looks at the issue of “IT Spend” most often expressed as Percentage of Revenue or Spend per Employee. In more traditional IT-environment
Based on the latest survey conducted by Colt, more than 68% of CIOs say they base high-pressure decisions on instinct and experience more than any other factor. Despite that, 76% admitted their instinct went against other sources, such as data or advice from third parties. The research findings indicate that lack of cohesion and
Cloudbyz has added eConsent feature to its CTMS product built 100% native on Salesforce.com cloud platform leveraging innovative Salesforce lightning. Cloudbyz CTMS eConsent replaces the paper based informed consent document with interactive, multi-media enabled and template driven informed consent on mobile devices.
Question number one highlights a common trap for many companies, approving all or almost all projects that get reviewed. This indicates that the project selection process is not working well. When governance councils have a project approval over 90%, it means very few projects are getting screened out and some poor projects are probably…
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