Best Clinical Trial Management System (CTMS) for Pharmaceutical Companies
In the pharmaceutical industry, where the stakes are incredibly high, managing clinical trials with precision, efficiency, and compliance is crucial. The complexity of drug development, coupled with...
Key Clinical Trial Acronyms You Need to Know in 2024
Navigating clinical trials can be challenging, especially with the plethora of acronyms that come your way. But don’t worry—this guide is designed to help you decode the essential terms of 2024,...
Strategies for Effective Clinical Data Management in 2024
Imagine a world where clinical trials are more efficient, data reliability is enhanced, and patient outcomes are significantly improved. As the landscape of clinical research evolves, so do the...
How to Find Investigators for Clinical Study
Finding the right investigators for any given study is one of the most critical tasks in a clinical research project. This is not only the task of finding the right people with appropriate...
Challenges of managing PHI & PII Data in Life Sciences and How AI/ML can help (2024 - Event - Webinar - PR & EDC - 23 May)
The challenge of managing and securing sensitive data, including PHI and PII, is significant for life sciences organizations. The volume of data that these organizations collect and process is...
Challenges of managing PHI & PII Data in Life Sciences and How AI/ML can help
The challenge of managing and securing sensitive data, including PHI and PII, is significant for life sciences organizations. The volume of data that these organizations collect and process is...
Enhancing User Experience for Study Teams in CTMS: A Comprehensive Guide
Clinical Trial Management Systems (CTMS) are vital tools for managing clinical trials. They streamline processes, improve efficiency, and ensure data accuracy, which is crucial for the success of...
Overcoming the Challenges of Adopting CTMS for Study Teams: A Comprehensive Guide
The adoption of Clinical Trial Management Systems (CTMS) by study teams brings numerous benefits, such as streamlined processes, improved efficiency, and better data accuracy. However, the...
Strengthening Clinical Trial Performance through Sponsor and Clinical Site Collaboration
The success of clinical trials is heavily dependent on effective collaboration between sponsors and clinical sites. Establishing a strong partnership can result in more efficient processes,...
Virtual Clinical Trials: How to Prepare for Success
As virtual clinical trials have found popularity, some sponsors and researchers have been hesitant to embrace it wholeheartedly. The COVID-19 pandemic has proven to be a universal disruptor in the...
Embracing the Future: The Benefits of Digitization in Pharmacovigilance
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It plays a crucial role in...
10 ways the new ChatGPT can revolutionize Pharmacovigilance
ChatGPT: The Future of Pharmacovigilance
Pharmacovigilance plays a critical role in monitoring drug safety post-approval. With the emergence of new technologies, there has been a growing interest in...
Optimizing Your Post-Marketing Research: The Key to Success
Pre-marketing drug studies vs Post- Marketing research
Pre-marketing drug studies consist of phase I-III trials, and are represented by pharmacokinetic and pharmacodynamic studies, dose ranging...
FDA Guidance for Industry: Providing Regulatory Submissions in Alternate Electronic Format
Issue Date: 24Jun2022
The US Food and Drug Administration has recently issued a final guidance for sponsors and applicants who receive an exemption or a waiver from providing regulatory submissions...
Defining Relevant Correspondence For ETMF: Best Practices And Considerations
Introduction to eTMF Correspondence
Electronic Trial Master Files (eTMFs) have revolutionized the way clinical trials are conducted and managed. This is because they allow organizations to digitize...
White Paper: Understanding Patient Recruitment and Retention
Author: Reeshav Mittal, Associate Director, Clinical Operations, Cloudbyz Inc.
Table of Contents
- Introduction
- What is RECRUITMENT? – SOME DEFINITIONS
- Major Critical Barriers to Patient Recruitment
Regulatory Compliance Coverage & Reference between FDA 21 CFR Part 11 and EU Annex 11
Until recently, clinical trials have been performed in a mostly paper-based processes. Advancements in technology, surge in remote work and digitization of the processes is driving the clinical...
Cloudbyz May CTMS Release Notes
Cloudbyz May CTMS Release Notes
Two new enhancements have been included to both Monitoring Reports and the Feasibility Survey. Also, enhancements in the user interface of eTMF...
Unified Clinical Trial Management Systems
Overview – What They Are
A Clinical Trial Management System (CTMS) is a software system that manages and organizes tasks and processes related to clinical trials. General CTMS features include...
Core eTMF Features and Practices
On April 13th, Cloudbyz hosted a webinar covering Core eTMF Features and Practices. Our in-house experts, Medha Datar and Reeshav Mittal explained in detail what an eTMF is, the benefits and core...
Cloudbyz & Salesforce: Sales Enablement Workshop
Cloudbyz and Salesforce Join Together for Clinical Trial Solutions Partner Enablement Event
Tuesday, March 22nd Cloudbyz joined Salesforce at their Chicago offices for a joint sales...
Solving Regulatory Challenges: CSV for Cloud-based Clinical Applications
A comprehensive session exploring the regulatory challenges for clinical application.
Rajendra Sadare, Head – Quality & Compliance from Cloudbyz goes deeper to explain the challenges, the...
Cloudbyz & Pharmetique Labs: Solving Challenges in Pharmacovigilance
A comprehensive session exploring how Cloudbyz Pharmacovigilance solution was deployed to address Pharmetique Lab’s business challenges and some of the lessons learned along the way.
Dr. Melissa...
Patient Engagement in Clinical Trials: Tech Enhancements
The success of clinical trials depends on multiple factors. Only a handful of those factors however, are irreplaceable. Factors being irreplaceable means that no amount of alternative resources can...
Wearables in Clinical Trials: An Overview of Challenges
Wearable Tech-What’s It All About?
Let’s start from the very beginning. What are people talking about when they say “wearables”, “wearable biosensors”, “wearable devices”, or “wearable technology”...
Machine Learning in Pharmacovigilance: Overview of Current and Potential AI Uses
Here’s a cliché: The future is here. Particularly for pharmacovigilance (PV) solution users. Anybody working with PV software solutions in the next few years is going to experience a major change;...
RBM Tech: How Software Helps Implement Risk-Based Monitoring
Co-authored by Reeshav Mittal (Clinical Trial Subject Matter Expert)
Within the clinical trial industry, Risk-Based Monitoring (RBM) is another rising trend that empowers research teams and...
6 Trends Shaping Clinical Trials in 2022
As a relatively young industry, it’s no wonder that the clinical trial industry tends to undergo rapid change. Although you may hear some argue that with regulations catching up, and a few COVID-19...
Recruitment in Clinical Trials – Part 3: Solutions & The Future
This article is the third part of a Cloudbyz article series about Recruitment & Retention in clinical trials. You can read the previous article in the series here.
Welcome to the third and final...
Biz in Cloudbyz Takes a Break on Children’s Day
On November 17th, Cloudbyz was privileged to take part in a day of music, fun and games at the Samarthanam Trust for the Disabled. Business took a backseat at...
Recruitment in Clinical Trials – Part 2: Challenges
This article is the second part of a Cloudbyz article series about Recruitment & Retention in clinical trials. You can read the previous article in the series here.
In the previous article, we...
Recruitment in Clinical Trials – Part 1: An Overview
This article is the first part of a Cloudbyz series of articles about Recruitment & Retention in clinical trials.
There are many challenges to recruitment in the field of clinical trials. There are...
Clinical Research : Digital Transformation Leveraging Salesforce
An hour-long virtual knowledge sharing session on Clinical Research: Digital Transformation Leveraging Salesforce
Event held on:4th November 2021
Cloudbyz delivered a comprehensive overview on...
Informed Consent in Clinical Trials: Nuances and Remedies
Whether you’re running a Decentralized Clinical Trial or a conventional clinical trial, obtaining informed consent from participants before involving them in clinical trials is legally paramount...
Decentralized Clinical Trials VS Conventional Clinical Trials: A Comparison
Co-authored by Reeshav Mittal(Clinical Trial Subject Matter Expert)
COVID-19 changed a lot of things. Forever. Arguably, in a good way. The changes I’m talking about are on the developmental...
Medical Device Safety: Digital Transformation Leveraging Salesforce
This video will comprehensively address the following key points:
1. Unifying Data in the Cloud for Real-time Visibility into Safety Operations2. Automating Safety Workflows for...
Pharmacovigilance: Digital Transformation Leveraging Salesforce
A 60 minutes virtual knowledge sharing session on Pharmacovigilance: Digital Transformation Leveraging Salesforce.
Event held on: 12th October 2021
Cloudbyz delivered a comprehensive...
Cloudbyz initiatives towards Corporate Social Responsibility
Cloudbyz,a fast-growing integrated Clinical Research and development solution provider in Healthcare & Life Science, has recently executed a CSR drive at the Samarthanam Trust for the Disabled...
Raising Clinical Trial Safety Standards With Cloudbyz Safety Management Solution
Overview
Cloudbyz has positioned itself as a reputable and highly preferred CTMS solution provider in the life science domain. We have received numerous positive responses and feedback...
Cloudbyz Resolves End-to-End Study Management Requirement of a Fortune 500 Company
Overview
Cloudbyz was approached by a US-based global Fortune 500, a wholesale drug distribution company with a business requirement for end-to-end study management. Being a large...
Cloudbyz has been recognised as a part of the Salesforce ecosystem
Cloudbyz has built innovative Clinical Trial Management solutions 100% native on the Salesforce platform. Cloudbyz has been driving the vision to help the clinical research industry to adopt and...
Why Did a Mega Information Services Company Approach Cloudbyz?
Overview:
Cloudbyz has a proven track record of value addition to customers in Sales Performance Management. Similarly, we were approached by an information service company with a...
Medhealth Outlook Places Cloudbyz in Top 10 Clinical Trial Management Solution Providers
Medhealth Outlook has included Cloudbyz in its list of top ten clinical trial management solution providers for 2020. Medhealth Outlook has come up with the list after a careful and comprehensive...
How Did Cloudbyz Deliver Data Efficiency to a Leading Medical Equipment Manufacturer
Overview
Cloudbyz was approached by a leadingUS-based manufacturer of medical equipment and related software specializing in radiation and oncology treatments.
Our client was a large...
How Cloudbyz Decentralized Clinical Trials Solution is Resolving the Industry Challenges
Decentralized clinical trials have been circulating around for some time now being addressed as virtual, remote, at-home, or siteless clinical trials. Whatever the name, the goals remain the same:...
What is a Virtual Clinical Trial and How Does it Benefit the Clinical Trial Industry (2021)
Introduction:
A virtual clinical trial (also known as remote or decentralized clinical trials) in the definition refers to digitally empowered clinical trial processes....
What to Include in the Clinical Trial Study Close-out Checklist
Study close-out is an essential factor in a clinical trial study. This process ensures that all the clinical trial activities are rightly reconciled, recorded, and reported at the end of the study...
How to Ensure Patient Safety During a Clinical Trial
Monitoring patient safety during a clinical trial is one of the founding principles to be followed throughout the drug development life cycle. It can be defined as a collaborative relationship...
How To Improve Your Study- Startup in Clinical Trials
Study startups(SSUs) define the process flow starting from the first point of contact with the sponsor to the screening and recruiting process of subjects by the study team in clinical trials.
...
6 Best Practices for Effective Collaboration Between Clinical Trial Sites, CROs, and Sponsors
The success of a clinical trial depends on the successful collaboration between sites, CROs, and sponsors. This means that timely andeffective communicationbetween the sites and the sponsors is...
6 Key Factors to Consider for Shortlisting Best CTMS Vendor
Investing in a CTMS is a big decision as it is the first step towards scaling up your operations in the clinical trial industry. Whether you’re kicking off your first trial or just migrating from...
How is Technology Used in Patient Recruitment and Engagement During Clinical Trials?
Clinical trial patients/subjects are the building blocks for any clinical trial study. It is on them that the entire research and development is based upon, tested, and approved for mass...
The Need for a Centralized Platform in Clinical Trials
Introduction:
Clinical research teams engaged in clinical trials are constantly challenged to do more with fewer resources. This has led to an extreme delay in the research outcome. Frankly, it takes...
How will Decentralized Clinical Trials (DCT) Dominate 2021
Introduction:
Decentralized clinical trials or DCT have become the new norm for the life sciences industry, particularly the clinical trial domain. The introduction of DCT has improved the...
Clinical Trial Budgeting – 6 Different Costs to Consider (2021)
Clinical trial budgeting is an essential aspect of running a clinical trial successfully. By definition, a clinical trial budget is the estimated amount of money that you need to complete the...
How to choose a reliable CTMS
So, you have decided to invest in a clinical trial management software or a CTMS to scale your operations or to transition from a legacy system to a more sophisticated approach, or simply because...
Pharmacovigilance: The need for a robust solution
WHO defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem.”
...
Digital transformation in patient recruitment and engagement activities
Digital technologies have disrupted almost all industries, and healthcare is not left behind. With the massive data set available at the fingertip, powerful innovations like AI, Internet of Things,...
Pharmacovigilance in times of COVID-19
The COVID-19 pandemic is ravaging the world in so many ways. It has affected and hit hard how clinical trials were done and managed in pre-COVID times. While the direct impact is definitely on...
Data management in a cloud-based world
Over the years, technology has made its way into different aspects of clinical trials bringing in significant progress in the field. There is no denying that in a clinical trial, the role of data is...
Prioritizing Communication Through an Integrated CTMS
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...
Virtual Trials and Technology Enablement
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...
15 Top Features to Consider While Procuring eConsent Solution
If you’ve been around the clinical research industry, the concept of obtaining electronic consent (eConsent) is probably familiar to you. Considering the current pandemic we are in, many sponsors,...
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...
6 Best Digital Solutions to Accelerate Patient Recruitment
Co-authored byDinesh 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 recruitment.
What is the scope of patient...
Working Solo Need Not Be a Silo!
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 and find lasting solutions. The five reasons why working from home involves...
Blending the Power of CTMS with IBM Merge
Clinical Trials, slowly but surely are becoming the new talking point of our generation. Even the teenagers of this contemporary age were discussing and searching about the clinical trials over the...
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...
The Unprecedented Growth of Cell and Gene Therapy
Introduction
Cell and gene therapy is an upcoming wave of therapeutic innovation in the healthcare and life sciences industry and is being pragmatically accepted worldwide. The gene therapy market...
The Plinth of Software Integration-In a Nutshell
The world perhaps is moving at a faster pace with substantial advancements in the technological sphere. Historians and scientists predict that the 21st century will be dominated by the trust-worthy...
4 Best Digital Developments in Clinical Trial Industry
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 – away where patient...
How Clinical Trial Sponsors Can Help During the Spread of COVID-19
3 Ways Sponsors Are Focusing Their Efforts in the Pandemic Era
As the spread of COVID-19 has affected every industry, pharmaceutical and biotech companies are feeling the heat of it. In ourlast piece
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...
Spreading Smiles One Step at a Time !!!
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...
Protocol Amendments – Causes, Impact and Strategies
Introduction
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...
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 two main reasons for the decreasing trend in the number offilings with the...
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...
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...
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 they are the values to be implemented....
Verily’s Project Baseline is Modernizing Clinical Trials
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...
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...
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...
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....
Cloudbyz CTMS and its Best Practices for Patient-Centric Clinical Trial
The modern jargon “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...
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...
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...
Benefits and Challenges of Virtual Clinical Trials
Virtual trials or siteless trials are defined as clinical trials/ clinical trial studies done partly or on the whole virtually. In this methodology, clinical research companies rely on mobile devices...
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...
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...
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....
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...
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...
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 patient care aspect is being automated. The impersonal nature of the bots has a benefit in various...
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...
Integrate IT Service Management and IT Portfolio Management
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 –...
The App Gap and Shadow IT
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.
We are well into the App Revolution, with all types of organizations...
The Current State of IT Portfolio Management Tooling
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?...
