CTMS

Cloudbyz offers a truly unified eClinical Trial Management Platform built natively on Salesforce, designed to streamline end-to-end clinical trial operations for Sponsors, CROs, and sites. The platform brings together Clinical Trial Management (CTMS), Electronic Trial Master File (eTMF), Electronic Data Capture (EDC), Clinical Trial Financial Management (CTFM), Randomization and Trial Supply Management (RTSM), Safety and Pharmacovigilance (PV), and Project Portfolio Management (PPM) into a single, integrated environment — delivering real-time visibility, faster study start-up, and full operational control across all clinical trial phases.

Recognized as a Major Contender in the Everest Group Life Sciences CTMS and EDC PEAK Matrix® Assessment, Cloudbyz serves top global CROs, medical device companies, pharma, and biotech organizations seeking to replace fragmented legacy systems with a cohesive, compliant, and data-driven platform.

Clinical Trial Management System (CTMS)

• Project Management — plan, track, and manage all trial activities from a single interface
• Feasibility Survey — assess and select sites efficiently before study start-up
• Study Budget Management and Projections — maintain financial oversight and forecast trial costs
• Site Payments — automate and track payments to investigative sites
• Monitoring (Central, Remote, and Risk-Based) — proactive monitoring with immediate access to critical metrics
• eDOA (Electronic Delegation of Authority) — manage site staff roles and responsibilities digitally
• Portals for Sites, Sponsors, and CROs — enable seamless collaboration across all stakeholders
• Training Management — track and manage required training for trial personnel
• Resource Management — allocate and optimize team resources across studies
• Integration, Reports, and Dashboards — real-time analytics and connectivity with other systems
• Unified with Cloudbyz eTMF, EDC, and Safety — single platform for complete trial visibility

Clinical Trial Financial Management (CTFM)

• Study Budget and Site Budget — create, manage, and track budgets at both study and site levels
• Study Visit Plan — align financial planning with visit schedules
• Collaboration via Investigator and Sponsor Portals — streamline budget negotiations and approvals
• MSA, Rate Card, and Budget Templates — standardize financial agreements and planning
• Workflow and Approvals — automate financial review and sign-off processes
• Reports and Dashboards — gain real-time insight and control over trial finances

Electronic Trial Master File (eTMF)

• Cloud-Based Document Repository — centrally store and manage study protocols, informed consent forms, investigator brochures, monitoring reports, and more
• TMF Reference Models and Automated Configurable Metadata — ensure documents are correctly classified and tagged
• eTMF Export and Locking — support trial close-out and archiving requirements
• Archiving and Retention — maintain documents in compliance with regulatory retention requirements
• Search and Retrieval — quickly locate documents across the TMF
• Real-Time Collaboration — share documentation with CROs, sponsors, monitors, and other stakeholders
• eISF Connectivity — link investigator site files to the central TMF
• TMF Health Check and Inspection Readiness — continuously monitor completeness and quality
• Milestone Tracking — align document collection with key study milestones
• AI eTMF Agent — automate document intake, classification, metadata capture, and quality control to reduce administrative burden and support GxP and inspection-readiness
• Unified with Cloudbyz CTMS, EDC, and Safety

Electronic Data Capture (EDC)

• Study Setup and Form Library (eCRFs) — configure studies and build electronic case report forms
• Rules Engine — apply automated data validation and edit checks
• Subject Management — track patient enrollment, visits, and status
• Randomization — manage subject randomization within the EDC
• Medical Coding — code adverse events and medical history using standard dictionaries
• ePRO/eCOA — capture patient-reported and clinical outcome assessments electronically
• Adverse Events and Protocol Deviation Management — record and manage safety and compliance events
• Query Management and Source Data Verification (SDV) — resolve data discrepancies efficiently
• Annotated eCRF and Data Export — support data review and submission activities
• Compliance and Data Security — meets FDA 21 CFR Part 11, GCP, GAMP5, HIPAA, and EU GDPR requirements
• Reports and Dashboards — real-time data quality and trial progress monitoring
• Unified with Cloudbyz CTMS, eTMF, and Safety

Randomization and Trial Supply Management (RTSM)

• Study Build and Cohort Management — configure complex study designs including multi-arm and stratified studies
• Randomization and Subject Replacement (Re-Randomization) — handle complex randomization schemes with ease
• IP Orders and Inventory Management — track investigational product supply, re-supply, and centralized inventory
• Patient Screening and Dispensing Management — manage drug dosing and dispensing at the site level
• IP Accountability and Reconciliation — maintain full accountability of investigational products
• Shipment Management — coordinate and track IP shipments to sites
• Threshold Management and Automated Orders — trigger automated replenishment based on inventory levels
• Emergency Unblinding (Code Breaking) — support urgent safety decisions
• Patient Portal and Investigator Portal — provide role-based access for patients and site staff
• Real-Time Recruitment and IP Availability Analytics — monitor supply and enrollment in real time
• Workflow and Notifications — automate alerts and approval processes

Safety and Pharmacovigilance (PV)

• Automated Case Intake — streamline the receipt and processing of adverse event reports
• Case Processing and Single Source of Truth — manage all safety data in one unified system
• WHO DD and MedDRA Medical Coding — apply standard medical terminology to safety cases
• Dynamic Auto Labelling and Auto Narratives — reduce manual effort in case documentation
• Medical Review — support clinical assessment of safety cases
• Regulatory Reports and e-Submissions — generate and submit ICSR and PS