Cloudbyz Pulse: June 2024

Welcome to the June edition of our newsletter!?

June is National Safety Month, a time to put a spotlight on safety in all our activities, particularly in clinical trials. Established by the National Safety Council in 1996, this observance aims to prevent injuries and deaths through awareness and proactive measures (NSC Save Lives ) (NSC Save Lives ).

At Cloudbyz, safety is at the core of our operations. Our Safety and Pharmacovigilance solutions are designed to protect trial participants and ensure data security and compliance. Let’s use this month to engage in training, revisit our safety practices, and support each other in maintaining a safe work environment.?

Thank you for prioritizing safety in everything you do. We hope you find this issue of our Newsletter both informative and interesting. Thank you for choosing Cloudbyz as your trusted partner in clinical research.

Highlights for This Month

Your Go-To Guide for Setting Up and Managing Clinical Operations

This guide covers everything your need to know to setup and manage clinical operations, right from Business Capability Map to solutions for clinical trial challenges. Learn more from this 19-step handbook for efficient clinical operations

Download Handbook

Navigating IVD Clinical Trials: Challenges, Best Practices, and eClinical Solutions

Signup for our upcoming webinar in July 2024!

What you'll learn:

1. Comprehensive Understanding of IVD Trials: Gain insights into the unique aspects and types of IVD clinical trials, including their regulatory and logistical challenges.
2. Ethical and Privacy Best Practices: Learn strategies to ensure ethical conduct and robust patient privacy protections in IVD trials, with real-world examples.
3. eClinical Platform Advantages: Discover how eClinical platforms enhance sample management, patient recruitment, and data management, improving trial efficiency and accuracy.

Sign up for Webinar

The Role of Modern EDC in Enhancing Patient-Centric Trials from Recruitment to Closeout

Watch on demand

Thank you to all who joined us last month as we explored the impact of modern EDC in patient centric trials. Incase if you've missed it and would like to know more, view the recording and access the slides anytime by clicking on the "Watch on Demand" button below.

Welcoming New Customer

Cloudbyz is thrilled to partner with our customer in their journey to co-create optimal solutions, build sustainable and scalable operating models that help reduce delays and drive consistency throughout the clinical research lifecycle. With Cloudbyz CTMS, Investigator and Sponsor portals, as well as integrations with third party softwares such as EDC and eTMF platforms, Cloudbyz CTMS will be a central database for all high level reporting.

We are excited to partner with our customer?and help them succeed in their endeavor to improve and digitalize their processes and workflows!

News from FDA: Recent Guidance

Understand Guidance | Access FDA Guidance PDF

Understand Guidance | Access FDA Guidance PDF

Customer Success

Our customer wished to integrate data across siloed platforms. With information across several standalone platforms, integration proved to be difficult. As a first step, Cloudbyz CTMS, Patient Recruitment, Randomization and Budgeting modules were implemented to streamline their clinical research workflows. With our inhouse clinical research subject matter experts helping them every step of the way, our customer started using these modules successfully and leveraged the benefits of a unified eClinical platform. The next challenge was consolidating all clinical trial documentation for regulatory submissions.

Cloudbyz's eTMF and Safety solutions, part of the unified clinical trial platform, provided an ideal solution to address their needs.

By adopting Cloudbyz eTMF and Safety solutions the organization is able to centralize all their study data on a single unified platform.?

SAE/ AE data brought in from EDC through integration was accessible seamlessly across CTMS for high level AE reporting and in the Safety platform. Relevant data collection and communication with sites was easy and in real-time through the use of the Investigator portal. Submission to regulatory authorities was smooth and seamless.

Adherence to regulatory requirements surrounding their clinical trials and being audit ready at all times was achieved through the adoption of e-TMF natively integrated with CTMS.

With robust reports and email notifications for key deliverables and data points, our customer?has been able to successfully resolve their core problem!

Product Updates

1. EDC (Electronic Data Capture)

• Scoring functionality to auto-calculate scores based on responses to questions in an ECRF / Form. This can be used for deriving the score on various standard physiological, and psychometric assessments typically used in diagnosis, hypothesis-testing, and ongoing evaluation of a subject’s progress in clinical trials.
• Ability to define a default role for study data access to a user assigned multiple roles in a study.
• Ability to define a default view for the association of ECRFs / Forms with visits and procedures.

2. Feasibility Survey

• Support for additional data types (Date, Date Time, and Whole number) in a survey

3. Budget Management

• Ability to choose a Visit plan version while defining a Visit-based Budget line item in the budget.
• Seamless orchestration with EDC process whereby accruals are generated automatically for visit-based subject costs when procedures for a subject are marked completed from EDC.

4. Monitoring Report

• Increase in the data/number of records of AEs, PD, eCRFs, ICFs, and Subjects monitored that can be added to Confirmation letters and follow-up letters.

Featured this Month

How the New EU AI Act Will Impact Clinical Trials in the Life Sciences?

Learn more

Understanding Oncology Trials: How eClinical Companies Make a Difference

Learn more

About?Cloudbyz

Cloudbyz’s unified e-Clinical platform streamlines clinical trial processes improves patient engagement and outcomes, and maximizes study data collection and integrity. Cloudbyz eClinical is the only Unified #ClinicalTrial Management platform built 100% native on Salesforce with integrated capabilities including #CTMS, #eTMF, #EDC, #Safety, #Pharmacovigilance.

Stay up-to-date with Cloudbyz 's latest news, updates, and insights. Subscribe to Cloudbyz Pulse today and never miss an issue. To connect with our team email us at [email protected] or visit cloudbyz.com/contact-us