Case study | Resources

Leveraging Tableau for Real-Time Signal Management Solution for Drug Safety and Efficacy

Real-time signal management can be a powerful tool in drug development, helping to detect potential safety and efficacy issues early on in the process.

Decentralized Clinical Trial Management: The Future of Clinical Trials

How Unified Clinical Trial Management Platform can enable Risk-Based Monitoring (RBM)

Unified clinical trial management platform can enable RBM by providing a centralized platform for risk assessment, data management

Virtual Clinical Trials: How to Prepare for Success

Learn the top 4 things to consider before setting up a virtual clinical trial. Get insights to ensure accurate results, participant safety, and data integrity.

11 Questions to Consider With EDC Vendor Selection

Selecting an EDC vendor is a critical decision that requires careful consideration. By asking these 11 questions, you can ensure that you

Electronic Patient Reported Outcome (ePRO) implementation Best Practices

ePRO implementation requires careful consideration of several key factors, including the selection of the right platform, patient engagement, data

Risk-Based Monitoring (RBM) in clinical trials: 12 Key Benefits

Implementing RBM in clinical trials can lead to a variety of benefits, including increased efficiency, cost savings, improved data quality, enhanced

Must have capabilities in pharmacovigilance solution

A pharmacovigilance solution must have a wide range of business, functional and technical capabilities to support the complex activities involved in ensuring patient safety.

Decentralized Clinical Trial Management: The Future of Clinical Trials

The decentralized clinical trial management platform built on the Salesforce platform provides

How CROs can improve their operations to better serve biotech companies

CRO and Biotech partnership is crucial to bring therapies faster to market. CROs can use these strategies to improver

Key alerts to setup on GCP violations during the clinical trial

Life science companies conducting clinical trials must adhere to GCP guidelines to ensure the safety

Cloudbyz Unified Clinical Trial Management Platform

Cloudbyz Unified Clinical Trial Management Platform is an innovative cloud-based software designed to streamline the clinical trial process, enabling greater efficiency, faster time-to-market, and reduced costs.

Manage end to end trial operations with Cloudbyz CTMS

Our Cloudbyz CTMS solution is an innovative cloud-based software designed to streamline the clinical trial management process, enabling greater efficiency, faster time-to-market, and reduced costs.

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. Digitally store, manage, and share clinical trial documentation centrally with actionable notifications.

Streamline Clinical data management with Cloudbyz EDC

Cloudbyz EDC solution is an innovative cloud-based software designed to streamline the clinical data collection process, enabling greater efficiency, faster time-to-market, and reduced costs.

Drug & Device Monitoring with Cloudbyz Safety & Pharmacovigilance

Cloudbyz Safety & Pharmacovigilance solution is an innovative cloud-based software designed to manage adverse events and ensure compliance with global pharmacovigilance regulations.

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 representing a significant bottleneck in the process.

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 guidelines for eCRF entry.

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 prices.

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 management, and biostatistics.

Clinical site initiation visit checklist and best practices

The clinical site initiation visit is a critical component of the clinical trial start-up process.

7 Reasons Why Digitizing Clinical Trial Budgets Is Vital

Clinical trials are a critical component of drug development in the life sciences industry.

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.

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.

Saving Time and Improving Quality: Medical Coding Automation in Pharmacovigilance

In pharmacovigilance, standardized classification and indexing of adverse drug reactions (ADRs) and other medical events are crucially important, and this is where medical coding comes in.

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.

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 Clinical Practice (GCP) guidelines and all regulatory requirements and also demonstrates that the integrity of trial data has been maintained.

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.

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.

10 ways the new ChatGPT can revolutionize 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 how they can revolutionize the field.

Optimizing Your Post-Marketing Research: The Key to Success

Pre-marketing drug studies consist of phase I-III trials, and are represented by pharmacokinetic and pharmacodynamic studies, dose ranging studies, and Randomized Controlled Trials (RCTs).

FDA Guidance for Industry: Providing Regulatory Submissions in Alternate Electronic Format

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 in electronic common technical document (eCTD) format.

Defining Relevant Correspondence For ETMF: Best Practices And Considerations

Electronic Trial Master Files (eTMFs) have revolutionized the way clinical trials are conducted and managed. This is because they allow organizations to digitize and centralize essential trial documents and data.

White Paper: Understanding Patient Recruitment and Retention

Nothing is of more importance to a clinical research study than recruitment and retention of participants in the study. In addition, losses to follow-up can destroy a study.

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 research industry and consequently, there is increased use of electronic records and electronic signatures to support these processes.

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 have been made.

Unified Clinical Trial Management Systems

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 complete management & maintenance for the functions of performance, planning, and reporting.

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 features of an eTMF, compliance requirements, as well as how to choose the right eTMF vendor.

Cloudbyz & Salesforce: Sales Enablement Workshop

Tuesday, March 22nd Cloudbyz joined Salesforce at their Chicago offices for a joint sales enablement event discussing both the clinical trial space and how Salesforce and Cloudbyz solutions help life science organizations get their products to market faster.

Solving Regulatory Challenges: CSV for Cloud-based Clinical Applications

A comprehensive session exploring the regulatory challenges for clinical application.

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.

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 make the trial successful.

Wearables in Clinical Trials: An Overview of Challenges

Let’s start from the very beginning. What are people talking about when they say “wearables”, “wearable biosensors”, “wearable devices”, or “wearable technology” in clinical trials?

Wearables in Clinical Trials: An Overview of Challenges

Let’s start from the very beginning. What are people talking about when they say “wearables”, “wearable biosensors”, “wearable devices”, or “wearable technology” in clinical trials?

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; working with PV solutions driven by machine learning (ML) algorithms.

RBM Tech: How Software Helps Implement Risk-Based Monitoring

Within the clinical trial industry, Risk-Based Monitoring (RBM) is another rising trend that empowers research teams and stakeholders to conduct clinical trials with greater flexibility in monitoring visits whilst continuing to gather reliable data.

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 setbacks and challenges, change isn’t happening fast enough, these 6 trends we’ve identified in clinical research will prove to you that change in the clinical trial industry shows no sign of slowing down anytime soon.

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.

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.

Recruitment in Clinical Trials – Part 1: An Overview

There are many challenges to recruitment in the field of clinical trials. There are also a number of solutions; some of them new and burgeoning, while others are tried and tested.

Clinical Research : Digital Transformation Leveraging Salesforce

An hour-long virtual knowledge sharing session on Clinical Research: Digital Transformation Leveraging Salesforce

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 in most jurisdictions.

Decentralized Clinical Trials VS Conventional Clinical Trials: A Comparison

COVID-19 changed a lot of things. Forever. Arguably, in a good way. The changes I’m talking about are on the developmental front. Clinical, managerial, and industrial discovery.

Medical Device Safety: Digital Transformation Leveraging Salesforce

An hour long virtual knowledge sharing session on Medical Device Safety: Digital Transformation Leveraging Salesforce.

Pharmacovigilance: Digital Transformation Leveraging Salesforce

A 60 minutes virtual knowledge sharing session on Pharmacovigilance: Digital Transformation Leveraging Salesforce.

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 transform clinical research processes to be patient and investigator centric.

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 assessment by its team of CEOs, industry experts, editorial board, and analysts.

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.

The Unprecedented Growth of Cell and Gene Therapy

Cell and gene therapy is an upcoming wave of therapeutic innovation in the healthcare and life sciences industry and is being pragmatically accepted worldwide.

What is a Virtual Clinical Trial and How Does it Benefit the Clinical Trial Industry (2021)

A virtual clinical trial (also known as remote or decentralized clinical trials) in the definition refers to digitally

What to Include in the Clinical Trial Study Close-out Checklist

How to ensure perfect clinical trial study close out with all regulatory checks? Read this blog to understand the 6 main components of the checklist.

How to Ensure Patient Safety During a Clinical Trial

Ensuring patient safety is of paramount importance. Here are 5 different ways to ensure patient safety during a clinical trial.

How To Improve Your Study- Startup in Clinical Trials

Study startups (SSUs) define the process flow starting from the

6 Best Practices for Effective Collaboration Between Clinical Trial Sites, CROs, and Sponsors

Are you dealing with underutilized site capacity? Or lagging effective site communication? Get such hindrances resolved with these 6 site efficiency-boosting tips.

The customer is a leading multinational pharmaceutical company based in India and overseas, and is committed to providing affordable and innovative medicine for healthier lives.

The customer is one of Australia’s largest CRO with a global footprint and specialization in early phase clinical trials.

The customer is a leading genetic testing company that operates as a CU A-certified laboratory in the US.

The customer is a fully integrated clinical research organization (CRO) that also manages a network of clinical research

The customer is a large multinational pharmaceutical company focused on the use of herbal medication as an effective

The customer is a leading medical imaging company which is committed to transforming the healthcare ecosystem by building

The customer is a global CRO and biopharmaceutical services company providing contract research, consulting

The customer is a Virtual Research Organization (VRO) and a leading player in the digitization of health innovation.

The customer is a leading biopharmaceutical company that aspires to improve patients' treatment outcomes and quality of life, targeting areas in autoimmune

The customer is a leading clinical-stage company advancing the development of novel immunotherapeutics designed to disrupt

The customer is a not-for-profit organization created by the World Health Organization to develop new treatments for drug-resistant infections that pose the greatest threat to health.

The customer is a global, science-oriented pharmaceutical company dedicated to the discovery, development

The customer is a strategic consulting firm which offers numerous products and services customized to fit biopharmaceutical

The customer is a leading medical devices company based in Denmark with presence across the United States.

The customer is a leading biotechnology company creating a new class of targeted gene therapies for debilitating

The customer is a medical technology company, that uses artificial intelligence and nano-technology to build platforms

The customer is a full-service, regulatory-inspected CRO specializing in Phase 1/2a, Human Abuse Liability

The customer is a global healthcare solutions company that help practices navigate the complexities of specialty care by delivering

The customer is a volunteer-centric CRO that assists in developing specialized medicines and therapies.

The customer is a global genomic diagnostic company that delivers best-in-class precision oncology tests to guide treatment management approaches.

Cloudbyz Unveils Groundbreaking Electronic Data Capture Solution to Streamline Clinical Research and Accelerate Launch of New Therapies

NAPERVILLE, Ill., March 15, 2023 /PRNewswire/ — Cloudbyz, a leading provider of unified clinical trial management solutions, today announced the launch of its innovative Electronic Data Capture

Cloudbyz Partners with Tech Mahindra to Provide Integrated Clinical Trial Management Solutions

NAPERVILLE, Ill., May 4, 2022 /PRNewswire/– Cloudbyz, a fast-growing integrated clinical research and development solution provider with integrated capabilities