The Power of Unified eClinical Platforms in Transforming Clinical Trial Operations
The landscape of clinical trials is increasingly complex, with growing regulatory demands, large volumes of data, and the pressure to bring therapies to market faster. To address these challenges,...
Pharmacovigilance solution on Salesforce platform
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It is a critical aspect of...
The Core Benefits of Seamless Automation in Drug Safety: A Future-Forward Approach to Pharmacovigilance
In today’s rapidly evolving pharmaceutical landscape, ensuring the safety of patients is a top priority. Drug safety, or pharmacovigilance, is the science of monitoring and assessing the adverse...
AI & Automation in Pharmacovigilance: Driving Efficiency and Compliance
Pharmacovigilance (PV) plays a critical role in ensuring drug safety and efficacy throughout a product’s lifecycle. Traditionally, PV activities such as adverse event reporting, signal detection, and...
Streamlining Clinical Trials: The Impact of Unified Management Platforms on Drug Development
The drug development process is often burdened by isolated legacy systems, disparate data sources, and inconsistent processes, leading to inefficiencies, increased costs, and delays in bringing new...
Transforming Clinical Trial Management: The Shift from Point Systems to Platform Solutions
The landscape of clinical trial management is undergoing a significant transformation, driven by the complex demands of modern medical research. At the heart of this change is a move away from...
Streamlining Global Regulatory Compliance with Cloudbyz Safety & Pharmacovigilance
In an era of increasing regulatory oversight and global harmonization in the life sciences industry, pharmaceutical, biotech, and medical device companies face numerous challenges in ensuring their...
Why Biotechnology start-ups must use midsize CRO to accelerate time to market
Biotechnology start-ups face unique challenges when it comes to bringing new products to market. They often have limited resources, smaller budgets, and less experience in the industry. As a result,...
Future-Proofing Your Safety & Pharmacovigilance Technology Platform
In today’s rapidly evolving regulatory landscape, organizations across the pharmaceutical, biotechnology, and medical device industries are increasingly challenged to ensure that their safety and...
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 these...
Practical Use Cases of Artificial Intelligence in Clinical Data Management
Artificial intelligence (AI) is revolutionizing numerous industries, and clinical research is no exception. Clinical Data Management (CDM) is at the heart of clinical trials, where data quality,...
Leveraging AI in Pharmacovigilance: How Cloudbyz is Shaping the Future of Drug Safety
Pharmacovigilance, the science and activities associated with the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems, has evolved significantly...
Customer Success Story: Global CRO Partners with Cloudbyz to Revolutionize Global Patient Recruitment
A leading global Clinical Research Organization (CRO), specializes in providing comprehensive clinical research and biopharmaceutical services, including contract research, consulting, medical...
What is Risk-Based Monitoring (RBM)?
Risk-Based Monitoring (RBM) is a modern approach to monitoring clinical trials that focuses on identifying, assessing, and mitigating risks to critical data and processes that affect the quality and...
What is Diversity Compliance in Clinical Trials Mandated by the FDA?
Diversity compliance in clinical trials refers to the requirement for pharmaceutical companies, contract research organizations (CROs), and other stakeholders to ensure that clinical studies include...
Revolutionizing Drug & Device Safety and Pharmacovigilance with Salesforce Agentforce
Ensuring drug and device safety is paramount in clinical research, not only for patient safety but also for meeting stringent regulatory requirements. Managing safety data, detecting adverse events,...
Unlocking Efficiency in Clinical Operations with Salesforce Agentforce and Cloudbyz eClinical Solutions
Clinical trials are intricate processes that involve numerous stakeholders, extensive data collection, and strict regulatory requirements. To address the growing complexities of clinical trials,...
AI Agents in Clinical Operations: Enhancing Efficiency, Quality, and Compliance
In the complex, regulated world of clinical operations, achieving the perfect balance between efficiency, quality, and compliance is a constant challenge. As clinical trials grow more sophisticated...
Accelerating Clinical Trials with EDC: Best Practices
Discover how Electronic Data Capture (EDC) systems are revolutionizing clinical trials by enhancing efficiency, accuracy, and speed.
The Role of EDC in Modern Clinical Trials
Electronic Data Capture...
What is Risk-Based Monitoring (RBM)?
Risk-Based Monitoring (RBM) is a modern approach to monitoring clinical trials that focuses on identifying, assessing, and mitigating risks to critical data and processes that affect the quality and...
What is Real-World Evidence (RWE)?
Real-World Evidence (RWE) refers to the clinical evidence generated from real-world data (RWD) collected outside the highly controlled environment of randomized clinical trials (RCTs). RWE is used to...
Streamlining Clinical Trials: The Case for Technology Consolidation to Drive Efficiency and Innovation
In the article "Why We Need Technology Consolidation In Clinical Trials," the author emphasizes the growing complexity of managing clinical trials due to the fragmentation of technological systems...
Integrating Drug Safety with Clinical Data Management: A Game Changer for Clinical Trials
In the increasingly complex world of clinical trials, integrating drug safety with clinical data management (CDM) systems is emerging as a critical innovation. This integration not only streamlines...
The Future of Decentralized Trials: How CTMS is Adapting
The clinical trial landscape is undergoing a transformative shift. Traditionally, clinical trials were conducted at centralized sites, with patients required to visit these locations for treatments,...
CTMS Point SaaS Solution vs. CTMS Platform SaaS Solution: A Detailed Comparison
In the rapidly evolving landscape of clinical trial management, organizations face a crucial decision: whether to adopt a CTMS (Clinical Trial Management System) point solution or a CTMS platform...
Implementing Drug Safety Solutions: Best Practices for Success
In today’s rapidly evolving pharmaceutical landscape, ensuring drug safety is more crucial than ever. With the increasing complexity of drug development and the growing emphasis on patient safety,...
The Future of Decentralized Trials: How CTMS is Adapting
The clinical trial landscape is undergoing a transformative shift. Traditionally, clinical trials were conducted at centralized sites, with patients required to visit these locations for treatments,...
Implementing Clinical Trial Participant Diversity Regulations in CTMS and EDC Systems
The need for diversity in clinical trials is not just a matter of ethical responsibility but also a scientific imperative. The FDA has recognized this and has laid out clear guidelines for enhancing...
Transforming Clinical Operations with Unified eClinical Platforms: How Integrating CTMS, EDC, eTMF, and Safety Systems Can Streamline Processes and Reduce Trial Timelines
In the rapidly evolving landscape of clinical research, efficiency and data integrity are paramount. As the complexity of clinical trials increases, life sciences organizations are seeking ways to...
Transforming Clinical Trials with Electronic Clinical Outcome Assessment (eCOA): A Paradigm Shift in Patient-Centered Research
In recent years, the life sciences industry has undergone a significant transformation driven by digital innovations. Among these advancements, Electronic Clinical Outcome Assessment (eCOA) has...
Unlocking Real-Time Clinical Data Management with Cloudbyz EDC: A Salesforce Native Solution
In the evolving landscape of clinical research, the stakes are high. The pressure to accelerate time-to-market, ensure regulatory compliance, and uphold data integrity requires advanced solutions...
Navigating the Complexities of Phase I Clinical Trials: Challenges, Insights, and Best Practices
Introduction
Phase I clinical trials mark a pivotal moment in the drug development process. As the first stage where an investigational drug is tested in humans, these trials are critical for...
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...
Transforming Clinical Study Build with Generative AI: Automating Data Extraction from Protocol Documents in Cloudbyz EDC
Introduction
Clinical research is a complex and highly regulated field where meticulous attention to detail is paramount. The process of building a clinical study can be both time-consuming and...
Unified Clinical Trial Management Systems: What They Are, Why They Matter, How to Choose Them
Overview – What They Are
AClinical Trial Management System (CTMS)is a software system that manages and organizes tasks and processes related to clinical trials. General CTMS features include...
Transforming Clinical Study Build with Generative AI: Automating Data Extraction from Protocol Documents in Cloudbyz EDC
Introduction
Clinical research is a complex and highly regulated field where meticulous attention to detail is paramount. The process of building a clinical study can be both time-consuming and...
The Global Landscape of Pharmacovigilance: A Comparative Analysis of Practices, Frameworks, and Collaboration Efforts
Pharmacovigilance, the science of monitoring and evaluating the safety of medications, plays a crucial role in safeguarding public health worldwide. However, the landscape of pharmacovigilance...
Discover the Power of Real World Evidence (RWE) on the Salesforce Platform
Welcome to our cutting-edge Real World Evidence (RWE) solution, harnessing the capabilities of theSalesforceplatform. Empower your healthcare organization with the ability to derive valuable...
Efficient Trial document management with Cloudbyz eTMF
Cloudbyz eTMF solution offers a cloud-based repository for all your clinical trial documents such as study protocols, informed consent forms, investigator brochures, monitoring reports, and others....
Transitioning from Traditional to Digital: The Medical Device Industry's Journey
With the advent of technology and increasing dependency on digital platforms, industries across the spectrum have had to adapt and evolve. One such sector that has seen dramatic transformation due to...
Sensory Analysis and Consumer Research in New Product Development: Unveiling the Key to Success
In the world of product development, understanding consumer preferences and perceptions is paramount to success. It is not enough to create innovative and technologically advanced products; they...
Sensory Analysis and Consumer Research in New Product Development: Unveiling the Key to Success
In the world of product development, understanding consumer preferences and perceptions is paramount to success. It is not enough to create innovative and technologically advanced products; they...
Clinical Trial Data Archiving: Ensuring Efficiency, Compliance, and Accessibility
Clinical trials are crucial for advancing medical research and developing innovative treatments. They generate a vast amount of valuable data, which needs to be securely archived for future...
Decentralized Clinical Trials: An In-depth Analysis
Introduction
In an increasingly digital age, healthcare is following suit by integrating digital technologies into its practices. This transformation has permeated the domain of clinical trials,...
Cloudbyz Pioneers Sustainability: Unleashing the Power of Regeneration
Cloudbyz, a global leader in digital transformation, announces an ambitious sustainability initiative that will set new standards in the technology industry and beyond. In a world where climate...
Mastering Sensory Research: Techniques, Best Practices, and Future Directions
As consumers, we are constantly engaging with the world through our senses. It’s the taste of our morning coffee, the smell of a new car, the texture of a soft sweater, the vibrant colors of fresh...
Navigating Digital Transformation in Clinical Trials: Essential Steps for eTMF Implementation
Electronic Trial Master Files (eTMFs) are rapidly becoming the norm in clinical trials, replacing paper-based TMFs with digital systems to store and manage essential documents. The...
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...
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...
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...
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...
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....
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,...
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...
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...
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...
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...
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...
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...
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...
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,...
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...
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...
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...
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...
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...
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...
Solutions to Improve Patient Enrollment and Retention in Clinical Trials
Clinical trials are essential for developing new treatments, to understand the efficiency and safety of the drugs to be used for treating Patients. People should be encouraged to participate in...
Webinar: Achieve Real-Time Visibility on Enterprise IT with Cloudbyz ITPM and BMC Remedyforce
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...
Webinar: Achieve Real-Time Visibility on Enterprise IT with Cloudbyz ITPM and BMC Remedyforce
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...
The Remedyforce Ecosystem Spotlight – Cloudbyz ITPM
A picture’s worth a thousand words, at least that’s how the saying goes. We at BMC Remedyforce are excitedto share a fantastic picture showing the ever evolving Remedyforce Ecosystem!
The picture...
Cloudbyz ITPM July 2017 Release Overview
Cloudbyz PPM July’17 release brings exciting new features that users requested and will find extremely useful. We have also fixed certain issues related to export of the project schedule to MS...
Benefits of Social Collaboration
Innovation is a hot topic in business right now with an ever growing need for companies to deliver better products and services. A key ingredient for fostering innovation is enterprise collaboration....
Integrated IT Portfolio Management in Digital Age
As digital transformation reshaping the enterprises across the industries, IT leaders recognize the need to innovate more, manage uncertainty better and establish more agility. However, they have to...
Accelerate Digital – Transformation With Real Time Visibility
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...
Improve Portfolio Health By Avoiding Two Portfolio Management Extremes
Two Simple Questions
You can measure your general portfolio health with two simple questions:
1) Do you approve all or almost all of your projects?
2) Are you approving so few projects that people...
Benefits of an eConsent Solution in Clinical Trials
Cloudbyz has added eConsent feature to its CTMS product built 100% native on Salesforce.com cloud platform leveraging innovative Salesforce lightning.
