Resource Library

Discover expert insights and best practices for Clinical Trial Management and learn how Cloudbyz can help you succeed

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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.

Cloudbyz CTMS eConsent replaces the paper based...