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Company description

Cloudbyz is a cloud-native eClinical solutions provider offering a truly unified Clinical Trial Management Platform built on Salesforce. The company serves sponsors, CROs, and clinical trial sites across all phases of clinical research, delivering end-to-end trial visibility, operational control, and compliance. Cloudbyz has been recognized as a Major Contender in the Everest Group Life Sciences CTMS and EDC PEAK Matrix® Assessment, and holds ISO 9001:2015 and ISO 27001:2022 certifications.

Founded with a vision to reinvent enterprise applications in the cloud for industry verticals, Cloudbyz is committed to building eClinical solutions that redefine patient experiences and elevate investigator and employee expectations. The company places customers and partners first, investing in innovation, sustainability, and community through its Pledge 1% membership and philanthropic programs.

Unified Clinical Trial Management Platform

• Cloudbyz's flagship offering is a unified eClinical platform that integrates all core clinical trial functions into a single Salesforce-native environment.
• The platform enables complete trial visibility, faster study start-up, and full operational control across planning, budgeting, monitoring, and close-out.
• It supports real-time collaboration among sponsors, CROs, sites, monitors, and other stakeholders.
• Core modules include CTMS, eTMF, EDC, Safety & Pharmacovigilance, CTFM, RTSM, PPM, and ClinicalWave.ai.

Clinical Trial Management System (CTMS)

• Cloudbyz CTMS provides integrated, end-to-end trial management with real-time visibility and analytics across all trial phases.
• Supports study planning, feasibility surveys, site payments, electronic Delegation of Authority (eDOA), training management, and resource management.
• Includes dedicated portals for sites, sponsors, and CROs to facilitate collaboration.
• Offers central, remote, and risk-based monitoring capabilities.
• Provides study budget management, financial projections, and integration with reports and dashboards.
• Natively unified with Cloudbyz eTMF, EDC, and Safety modules.
• A leading medical device company reduced monitoring costs using Cloudbyz CTMS by replacing legacy systems with real-time insights and proactive monitoring.
• A top global CRO adopted Cloudbyz CTMS to move from fragmented systems to a unified platform, achieving faster decisions, reduced errors, and shorter timelines.

Clinical Trial Financial Management (CTFM)

• Cloudbyz CTFM gives organizations visibility, insight, and control over clinical trial finances.
• Supports accurate financial forecasting, study budget management, and tracking of site budgets and payments.
• Features include study budget, site budget, study visit plan, MSA and rate card management, budget templates, workflow and approvals, and reports and dashboards.
• Includes investigator and sponsor collaboration portals for streamlined financial communication.

Electronic Trial Master File (eTMF)

• Cloudbyz eTMF is a cloud-based repository for all clinical trial documents, including study protocols, informed consent forms, investigator brochures, and monitoring reports.
• Enables digital storage, management, and sharing of trial documentation with a centralized overview.
• Provides real-time visibility and collaboration for CROs, sponsors, monitors, and other stakeholders.
• Key capabilities include eTMF export, TMF reference models, eTMF locking, real-time collaboration, TMF health checks, and inspection readiness.
• Includes an AI eTMF Agent that automates document intake, classification, metadata capture, and quality control, allowing TMF teams to focus on oversight rather than administrative tasks. Built for GxP compliance and inspection readiness.

Electronic Data Capture (EDC)

• Cloudbyz EDC enables real-time data collection, reduces redundancies, and enhances overall data quality across clinical trials.
• Fully integrated within the unified eClinical platform for seamless data flow.

Safety & Pharmacovigilance (PV)

• Cloudbyz Safety & PV provides a robust, secure, and compliant platform for managing all safety and pharmacovigilance processes.
• Designed to support end-to-end safety reporting and regulatory compliance requirements.

ClinicalWave.ai — AI-Powered Document Intelligence

• ClinicalWave.ai is an advanced AI and machine learning solution for intelligent source document identification and redaction.
• Uses machine learning algorithms to detect and classify sensitive information within documents, including personal details, financial data, and proprietary content.
• Automates redaction to ensure privacy and compliance, streamlining workflows and enhancing document security.
• clinRedact AI: Automated data redaction for clinical documents.
• clinExtract AI: Automated data extraction from clinical documents.
• clinDICOM AI: Automated redaction of DICOM imaging data.

Project Portfolio Management (PPM) & Randomization and Trial Supply Management (RTSM)

• Cloudbyz PPM supports portfolio-level planning and oversight across multiple clinical programs.
• RTSM (Randomization and Trial Supply Management) is included as part of the unified platform to manage trial supply logistics and patient randomization.

Platform & Compliance Highlights

• Built natively on the Salesforce platform, enabling enterprise-grade security, scalability, and integration capabilities.
• ISO 9001:2015 and ISO 27001:2022 certified.
• Designed for GxP compliance and regulatory inspection readiness.
• Trusted by top global life sciences companies, including leading medical device companies and top-tier CROs.
• Supports integration with external systems and provides comprehensive reports and dashboards across all modules.

Cloudbyz combines deep life sciences domain expertise with cutting-edge cloud and AI technology to help sponsors, CROs, and sites conduct clinical trials more efficiently, compliantly, and collaboratively. With a customer-first mission and a culture grounded in trust, innovation, and empowerment, Cloudbyz continues to advance the future of clinical research operations.

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Software attributed to Cloudbyz

• CTMSView
• eTMFView
• EDCView
• Safety & PharmacovigilanceView
• ClinicalWave.aiView
• clinRedact AIView
• clinExtract AIView
• clinDICOM AIView

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