Cloudbyz eTMF on Salesforce: Meeting and Exceeding eTMF Capability Requirements
Cloudbyz eTMF is a comprehensive Electronic Trial Master File (eTMF) solution built on the Salesforce platform. It is designed to streamline clinical trial document management, enhance...
What Drives Clinical Trial Costs? A Comprehensive Exploration
Clinical trials play a vital role in bringing new therapies and treatments to patients, but they can be expensive and resource-intensive endeavors. Understanding the factors driving clinical trial...
Leveraging Automation to Enhance eTMF Workflows and Efficiency
The automation in Electronic Trial Master File (eTMF) systems offers the potential to revolutionize the way clinical trial documentation is managed. By leveraging Cloudbyz eTMF solutions built on...
Comprehensive eTMF Capabilities and Evaluation Criteria
The successful implementation of an Electronic Trial Master File (eTMF) system is critical for clinical research organizations seeking to streamline their document management processes, improve...
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...
Understanding Clinical Trial Budget Structure: A Comprehensive Guide
Developing a well-structured and comprehensive clinical trial budget is crucial for the successful execution of a clinical trial. It not only helps in monitoring and controlling costs but also...
Uncovering Hidden Costs in Clinical Trial Budget Management: Checklist
Clinical trial budget management is a complex yet crucial aspect of conducting a successful clinical trial. One of the most challenging tasks for project managers and sponsors is to identify and...
Unlocking the Full Potential of Electronic Data Capture (EDC) built on the Salesforce Platform
Cloudbyz,a prominent provider of innovative software solutions, offers a robust Electronic Data Capture (EDC) system built on the Salesforce platform. This powerful combination empowers...
Accelerating Time to Market: Why Biotechnology Start-ups Must Utilize Midsize CROs
The biotechnology industry has experienced rapid growth over the past few years, with numerous start-ups emerging to develop innovative therapies, diagnostics, and solutions for a wide range of...
EU MDR: 10 Essential Things Sponsors Should Know
The European Union Medical Device Regulation (EU MDR) came into force on May 26, 2021, and has significantly impacted the medical device industry. As a sponsor of medical devices, it’s crucial to...
Process Automation in Medical Device Safety Operation: Best Practices
Medical device safety activities involve a range of ongoing efforts aimed at ensuring that medical devices are designed, manufactured, and used in a manner that minimizes harm to patients. Some of...
A Comprehensive Guide to Pharmacovigilance Regulatory Reporting: Ensuring Patient Safety and Compliance
Pharmacovigilance plays a pivotal role in safeguarding patients from potential adverse effects and ensuring the safety of drugs and medical devices. A vital aspect of pharmacovigilance is...
Integrating ESG in Drug Development Strategy for Pharmaceutical Companies
Environmental, Social, and Governance (ESG) considerations are becoming increasingly important for businesses across industries, including pharmaceuticals. This white paper provides an in-depth look...
The Importance of Integration Between eTMF, EDC, and CTMS Systems
The clinical trial landscape is continuously evolving, with technology playing a crucial role in streamlining processes, managing data, and improving efficiency. Three essential systems that have...
Unlocking the Potential of Electronic Trip Reports in CTMS Platforms
In recent years, Clinical Trial Management Systems (CTMS) have revolutionized the way clinical trials are conducted, offering numerous advantages to research organizations, pharmaceutical companies,...
Empowering Real World Evidence (RWE) Generation with Unified Platforms
The landscape of clinical research is rapidly transforming, with Real World Evidence (RWE) playing an increasingly crucial role in this evolution. RWE refers to data derived from real-world...
Clinical trial management roles and responsibilities at Sponsor, CRO, and Clinical Site
Clinical trials are an essential part of the drug development process. They are designed to ensure that new drugs and treatments are safe, effective, and reliable before they are made available to...
EU Clinical Trial Regulation: 10 things sponsors should know
The European Union (EU) Clinical Trial Regulation (CTR) No 536/2014, which came into effect in January 2022, has significantly changed the clinical trial landscape in the EU. It streamlines...
Understanding the New EU Clinical Trial Regulation
Introduction:
The new European Union (EU) Clinical Trial Regulation (CTR), Regulation (EU) No 536/2014, came into force in January 2022, replacing the previous EU Clinical Trials Directive...
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,...
Advancing Medical Science: How Clinical Trials Fit Within Large Healthcare Systems
Clinical trials are an important part of the healthcare system, as they provide patients with access to innovative treatments that may not be available through traditional treatment options....
Unlocking the Benefits of a Platform Approach to Digital Transformation in Clinical Trial Management
A platform approach can provide a comprehensive solution for digital transformation in clinical trial management, enabling stakeholders to access and share data, collaborate, and manage the clinical...
10 Reasons Why Your Site Needs a CTMS and Payments Solution for Clinical Trials
Clinical trials are complex and expensive endeavors that require meticulous planning, coordination, and execution. The success of a clinical trial depends on various factors, including...
Saving Costs and Improving Efficiency in Clinical Trials: The Benefits of a Unified Management Platform
Clinical trials are crucial in advancing medical research and finding new treatments and cures for various diseases. However, the process of managing clinical trials is complex and time-consuming,...
Choosing the Best CTMS: A Guide to Selecting the Right Solution for Your Clinical Trials
Clinical trial management systems (CTMS) are software solutions designed to help manage clinical trials. They provide a range of tools for study management, including tracking patient...
Optimizing Clinical Trials with Unified Trial Management: Streamlining Processes and Ensuring Future Success
A Comprehensive Look at the Modernization of Clinical Trials through Unified Trial Management
Introduction:
Clinical trials are essential for the advancement of medicine and healthcare. As...
Accelerate Clinical Trials with a unified clinical trial management platform
Clinical trials are complex and resource-intensive endeavors, and as such, there is an increasing need to streamline clinical trial operations and increase operational efficiency. A unified...
How to address 21 CFR Part 11 compliance requirements when considering ChatGPT in Clinical Trial Operations
21 CFR Part 11 is a regulation set by the US Food and Drug Administration (FDA) that outlines the criteria for electronic records and electronic signatures to be considered as reliable,...
Digital Transformation in Clinical Trial Management: Challenges, Processes, and Benefits in the Pharmaceutical Industry
Digital transformation is the process of using digital technologies to change how organizations operate and deliver value to customers. The pharmaceutical industry has been undergoing a...
Things to consider while evaluating electronic data capture (EDC) solution
Electronic data capture (EDC) solutions are software platforms used by researchers, clinicians, and other healthcare professionals to collect, manage, and analyze data from clinical trials or...
Improving Clinical Trial Efficiency with Integrated Imaging on a Unified Management Platform: Benefits and Best Practices
Clinical trials are an essential aspect of the drug development process. They are conducted to evaluate the safety and efficacy of new treatments, medications, or medical devices. Clinical...
How Cloudbyz unified Clinical Trial Management Solution can help the life sciences industry
Cloudbyz Unified Clinical Trial Management Solution (CTMS) is a comprehensive cloud-based platform that streamlines the management of clinical trials.
Cloudbyz Unified Clinical Trial...
10 considerations in digitizing medical device safety operations to achieve operational efficiency
10 considerations in digitizing medical device safety operations to achieve operational efficiency
The medical device industry is constantly evolving, and with that evolution comes an...
Critical Capabilities, Considerations, and Benefits of E2B Gateway for Improved PV Operations Efficiency
Electronic-to-business (E2B) gateway is an automated system that facilitates the electronic submission of pharmacovigilance data from pharmaceutical companies to regulatory authorities. The...
Promoting Sustainable Practices for Improved Health Outcomes
Chronic diseases such as heart disease, diabetes, cancer, and respiratory diseases are major health concerns that can significantly impact an individual’s quality of life. However, by...
Cloudbyz Safety & Pharmacovigilance Solution Overview
Cloudbyz Safety & Pharmacovigilance solution is a comprehensive platform that delivers end-to-end support for all pharmacovigilance activities. It is designed to help healthcare organizations...
Reducing Environmental Impact in Clinical Trials: Best Sustainable Practices
Clinical trial management involves various activities and processes that can have a significant impact on the environment and contribute to sustainability issues. Sustainability is becoming...
How to Accelerate Site Activation: Best Practices
Accelerating clinical site activation is crucial to ensure timely initiation of clinical trials and efficient resource utilization. By streamlining this process, sponsors and clinical...
Adverse Events Medical Coding and Review: Best Practices
Introduction
Medical coding is a crucial process in healthcare that helps to ensure accurate billing and reimbursement, as well as effective tracking of patient outcomes. Adverse events, also...
How Cloudbyz Unified Clinical Trial Management Solution can help in Unlocking academic research institute’s true potential
Academic research institutes play a critical role in advancing scientific knowledge and developing new treatments for diseases. However, managing clinical trials is a complex and...
Streamlining Clinical Trials with Unified Clinical Trial Management Platforms
Clinical trials are essential for the development of new therapies and treatments, and they require the coordination of multiple stakeholders, including study sponsors, investigators,...
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”...
