Challenges in paper based data collection in clinical trials
Clinical trials are an essential part of medical research that involves testing new drugs, treatments, and medical devices. The data collected during these trials are crucial for ensuring patient...
How AL/ML based solution can help extract clinical data from Source and CRF documents in a clinical study
Source documents and case report forms (CRFs) are two types of documents that are commonly used in clinical trials to collect clinical data. However, the manual extraction of relevant clinical data...
12 things to consider in implementing risk-based monitoring (RBM)
Risk-based monitoring (RBM) is a clinical trial monitoring approach that focuses resources on areas that pose the greatest risk to data quality and patient safety. The RBM approach is gaining...
Demystifying 10 Myths About the Decentralized Clinical Trial Platform
Clinical trials are crucial in bringing new treatments and therapies to patients. However, traditional clinical trial processes are often time-consuming, costly, and inefficient. Decentralized...
How AI/ML based PHI & PII redaction solution can help Clinical Research
AI/ML-based PHI and PII redaction solutions can help in clinical research by automating the process of identifying and redacting sensitive information from documents, images, and other digital...
What data management reports are needed to run the clinical study?
Clinical studies are essential for the advancement of medical research and the development of new treatments, drugs, and medical devices. Clinical studies collect valuable data, which is used to...
Navigating operational challenges for Cell & Gene Therapy Trials
Cell and gene therapies are rapidly becoming an essential component of modern medicine, offering hope to patients with previously untreatable diseases. These therapies are often based on...
How AI/ML-based PHI & PII redaction solutions can help life sciences organizations
In today’s digital age, life sciences organizations are collecting, storing, and processing vast amounts of sensitive data, including personally identifiable information (PII) and protected health...
How small biotech companies can work with CRO and how to keep costs down
Small biotech companies often face significant challenges when it comes to managing clinical trials and bringing their products to market. One of the key ways that these companies can overcome...
Cloudbyz eClinical: Life Sciences Industry Cloud on the Salesforce Platform
Cloudbyz specializes in providing cloud-based solutions for the healthcare industry. One of its flagship offerings is its eClinical Cloud, built on theSalesforceplatform. This solution is...
Leveraging Tableau for Real-Time Signal Management Solution for Drug Safety and Efficacy
Abstract
Real-time signal management is a critical process in drug development that involves the continuous monitoring of data to identify and respond to potential safety and efficacy issues. To...
How Unified Clinical Trial Management Platform can enable Risk-Based Monitoring (RBM)
A unified clinical trial management platform can enable risk-based monitoring (RBM) in clinical trials by providing a centralized platform for data management, monitoring, and reporting.
A unified...
11 Questions to Consider With EDC Vendor Selection
Electronic Data Capture (EDC) is a technology used in clinical trials to collect, manage, and analyze data generated during the study. EDC systems have become a vital part of clinical research...
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...
Risk-Based Monitoring (RBM) in clinical trials: 12 Key Benefits
Risk-based monitoring (RBM) is a clinical trial monitoring approach that focuses resources on areas that pose the greatest risk to data quality and patient safety. The RBM approach is gaining...
Must have capabilities in pharmacovigilance solution
Pharmacovigilance is a crucial aspect of the healthcare industry, as it involves the detection, assessment, understanding, and prevention of adverse effects associated with the use of medications....
Decentralized Clinical Trial Management: The Future of Clinical Trials
Decentralized Clinical Trial Management is a new approach to conducting clinical trials that leverages decentralized technologies such as blockchain, smart contracts, and distributed computing to...
How CROs can improve their operations to better serve biotech companies
Contract Research Organizations (CROs) play a crucial role in helping biotech companies conduct clinical trials and bring drugs to market. Here are some ways that CROs can improve their operations...
Key alerts to setup on GCP violations during the clinical trial
Good Clinical Practice (GCP) is an international standard that outlines ethical and scientific quality requirements for designing, conducting, recording, and reporting clinical trials involving...
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...
EDC: Clinical study build checklist
Building an electronic data capture (EDC) system for a clinical study involves several steps that must be carefully planned and executed to ensure data accuracy, completeness, and security. Here is...
Clinical Trial Data Management Best Practices
Clinical trial data management involves collecting, processing, analyzing, and reporting data from clinical trials in a systematic and efficient manner. Effective data management is critical for...
Clinical Data Management in Decentralized Clinical Trials: Data Manager Perspective
Decentralized clinical trials (DCTs) are becoming increasingly popular as they offer many advantages over traditional clinical trials. DCTs can reduce the need for patients to travel long distances,...
Clinical site qualification visits best practices
Clinical site qualification visits are an essential step in ensuring that clinical trial sites are qualified to conduct a study. These visits allow sponsors and contract research organizations (CROs)...
How artificial intelligence can help clinical data management
Artificial intelligence (AI) has the potential to revolutionize clinical data management (CDM) by automating many time-consuming tasks and improving the accuracy and efficiency of data analysis. In...
7 Benefits of integrating EDC with CTMS, eTMF and Safety
Integrating electronic data capture (EDC) with other clinical trial management systems like clinical trial management systems (CTMS), electronic trial master files (eTMF), and safety systems can...
How digital platforms can transform medical device safety operations
The medical device industry is constantly evolving, and with that evolution comes an increased need for more efficient and effective ways to ensure the safety and reliability of these devices....
Accelerating medical device launch with a Unified Clinical Trial Platform
The medical device industry is one of the fastest-growing industries globally, with innovation driving the development of new and improved devices. However, getting these devices to market requires...
10 Important Metrics in Clinical Data Management
Clinical Data Management is a critical component of clinical research, as the accuracy and completeness of the data collected are essential to support the safety and efficacy of new drugs, medical...
Transforming Clinical Site Operations with a Unified Digital Platform
Clinical site operations refer to the management and coordination of clinical trials, which are crucial for the development and approval of new medical treatments. These operations involve multiple...
Writing eCRF Entry Guidelines
Electronic case report forms (eCRFs) are used in clinical trials to collect and manage patient data electronically. To ensure accurate and consistent data entry, it is important to establish...
Accelerating Biotech Therapy Launch with a Unified Clinical Trial Platform
Biotech start-ups are focused on bringing innovative therapies to market as quickly as possible. However, the path from drug discovery to commercialization is long and complex, with clinical trials...
MDCG regulatory reporting guidelines
The Medical Device Coordination Group (MDCG) is a regulatory body in the European Union (EU) responsible for developing guidelines and regulations related to medical devices. MDCG regulatory...
How midsize CROs can use unified clinical trial management platform to achieve competitive advantage
In today’s competitive landscape, midsize Contract Research Organizations (CROs) are under constant pressure to stay ahead of the curve by providing quality clinical trial services at competitive...
Clinical site initiation visit checklist and best practices
The clinical site initiation visit is a critical component of the clinical trial start-up process. It involves the CRA visiting the study site to ensure that the site is prepared to conduct the study...
Unique challenges that midsize CROs face and how they can address them
Mid-size Clinical Research Organizations (CROs) play a significant role in the pharmaceutical and biotech industry by providing various services such as study design, clinical trial management, data...
7 Reasons Why Digitizing Clinical Trial Budgets Is Vital
Clinical trials are a critical component of drug development in the life sciences industry. Conducting clinical trials requires significant investments of time and resources, including the management...
Pharmacovigilance Made Easy with Salesforce-Based Platform
The pharmaceutical and life sciences industry considers pharmacovigilance a critical function that involves identifying, assessing, and preventing adverse effects or other drug-related problems. To...
Steps to follow for successful TMF regulatory inspections
A Trial Master File (TMF) is a comprehensive collection of documentation that provides a complete record of a clinical trial. The TMF contains all essential documents related to the trial, such as...
Saving Time and Improving Quality: Medical Coding Automation in Pharmacovigilance
Medical coding in pharmacovigilance:
In pharmacovigilance, standardized classification and indexing of adverse drug reactions (ADRs) and other medical events are crucially important, and this is...
Unified Clinical Trial Management: The Key To Improved Efficiency And Productivity
Clinical trials are complex and resource-intensive endeavors. Therefore, there is an increasing need to streamline clinical trial operations and increase operational efficiency. One solution to...
Integrate QMS and Unified CTMS for improved operations
Quality Management Systems (QMS) are an essential component of clinical operations as they manage the quality of clinical research. QMS define, document, and implement standard operating procedures...
The Ultimate Guide to TMF Inspection: A Comprehensive Checklist
A Trial Master File (TMF) is a comprehensive collection of documentation that provides a complete record of a clinical trial and proves that a clinical trial has been conducted following Good...
How to avoid GCP violations at clinical sites
Good Clinical Practice (GCP) guidelines provide a framework for the design, conduct, and reporting of clinical trials. The guidelines aim to ensure that the rights, safety, and well-being of trial...
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...
Salesforce Flows – A How-to Guide
In this blog we will learn Salesforce flow and how it is similar to apex coding.
Salesforce flow is a declarative way (Drag & Drop) of implementing an automation that is required for a business...
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...
