Clinical Trial Management System (CTMS)

Cloudbyz CTMS is an integrated clinical trial management solution that offers end-to-end trial management with real-time visibility and analytics across study planning, budgeting, start-up, study management, and close-out. Manage end-to-end trial operations with Cloudbyz CTMS.

Our integrated solution with a customer-centric approach supports Sponsors, CROs, and sites in conducting clinical trials efficiently across all clinical trial phases.

• Project Management

• Projections

• Feasibility Survey

• Study Budget Management

• Site Payments

• Monitoring (Central/Remote/Risk Based)

• eDOA

• Portals (Site/Sponsor/CRO)

• Training Management

• Resource Management

• Integration, Reports & Dashboards

• Unified with Cloudbyz eTMF, EDC, & Safety

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Clinical Trial Budget Management (CTBM)

Cloudbyz, Clinical Trial Budget Management solution, helps organizations gain visibility, insight, and control of the finances of clinical trials. The solution helps in accurate financial forecasting, study budget management, and tracking site budgets and payments.

• Study Budget

• Site Budget

• Study Visit Plan

• Collaboration - investigator & sponsor portals

• MSA, Rate Card & Budget Templates

• Reports and Dashboards

• Workflow and Approvals

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Electronic Trial Master File (eTMF)

Cloudbyz eTMF solution offers a cloud-based repository for all clinical trial documents, such as study protocols, informed consent forms, investigator brochures, monitoring reports, etc. Digitally store, manage and share clinical trial documentation with a centralized overview. Stay inspection ready, and provide real-time visibility of study documentation to CROs, sponsors, monitors, and other stakeholders in a clinical trial.

• eTMF Export

• Automated & Configurable Metadata

• TMF Reference Models

• Archiving & Retention

• eTMF Locking

• Search & Retrieval

• Real-Time collaboration

• eISF Connectivity

• TMF Health check

• Inspection Readiness

• Milestone Tracking

• Unified with Cloudbyz CTMS, EDC, & Safety

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Electronic Data Capture (EDC)

Cloudbyz EDC is a user-friendly, cloud-based solution designed to store and manage clinical data effectively throughout a clinical trial's life cycle. Our innovative solution enables clinical research teams to efficiently collect, analyze, and manage clinical data of different complexity and size. Cloudbyz EDC is a scalable solution and meets all the essential regulatory compliance requirements, such as FDA 21 CFR Part 11, GCP, GAMP5, HIPAA, and EU GDPR.

• Study Setup & Form Library (eCRFs)

• Rules Engine

• Subject Management

• Randomization

• Medical Coding

• ePRO/eCOA

• Adverse Events & Protocol Deviation

• Query Management & SDV

• Annotated eCRF & Data Export

• Compliance & Data Security

• Reports & Dashboards

• Unified with Cloudbyz CTMS, eTMF, & Safety

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Randomization & Trial Supply Management (RTSM)

Cloudbyz’s Randomization and Trial Supply Management (RTSM) solution is a robust solution that performs all tasks related to trial supply management, such as tracking of Investigational Product supply and re-supply, drug dosing and dispensing, centralized inventory tracking, threshold management, automated orders, and notifications. The system effortlessly handles complex randomization schemes and has provisions for stratification and multi-arm studies.

• Study Build

• Real-Time Recruitment & IP Availability

• Cohorts

• Emergency Unblinding (Code Breaking)

• Randomization

• Investigator Portal

• IP Orders Management

• Real-time Analytics with Reports and Dashboards

• IP Inventory Management

• Automatic inventory & Utilization Level Monitoring

• Patient Screening & Dispensing Management

• IP Accountability & Reconciliation

• Shipment Management

• Subject Replacement (Re-Randomization)

• Patient Portal

• Workflow & Notifications

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Safety & Pharmacovigilance (PV)

Cloudbyz Safety and Pharmacovigilance (PV) software is a cloud-based solution built natively on the Salesforce platform. It offers 360-degree view across R&D and commercial. It also enables companies with pharma, biotech, and medical devices to make faster and better safety decisions. Optimize global pharmacovigilance compliance with an easy-to-integrate risk management feature.

• Automated Case Intake

• Case Processing

• Single Source of Truth

• WHO DD/ MedDRA Medical Coding

• Dynamic Auto Labelling.

• Monitoring & Notifications

• Auto Narratives & Medical Review

• Configurable Workflow Automation

• Regulatory Reports & e-Submissions

• Interactive Reports & Dashboard

• AI/ML & NLP

• ICSR & PSR E2B R2 & R3

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ClinicalWave.ai

Introducing an advanced AI-ML solution for intelligent source document identification and redaction. Our cutting-edge technology utilizes machine learning algorithms to swiftly detect and classify sensitive information within documents. With automated precision, confidential data like personal details, financials, or proprietary content is promptly redacted, ensuring privacy and compliance. Experience streamlined workflows, enhanced security, and peace of mind with our state-of-the-art solution. Revolutionize your document management with ease!

• clinRedact AI

  Discover seamless data redaction solutions.

• clinExtract AI

  Discover seamless data extraction solutions.

• clinDICOM AI

  Discover seamless DICOM data redaction solutions.

Project Portfolio Management (PPM)

Cloudbyz PPM enhances organizational performance by providing real-time visibility, actionable insights, and control across all projects managed and executed within the enterprise. It helps align resources and projects with business goals and control costs through increased efficiency and optimized resource utilization.

With Cloudbyz PPM, stakeholders can easily access relevant information about ongoing projects, enabling executives to allocate and utilize resources most effectively.

• Centralized project portfolio management

• Support for Waterfall, Agile, and Hybrid methodologies

• Efficient resource allocation and utilization

• Timesheet management

• Effective risk and issue management

• Template-driven project scheduling - comprehensive pre-built reports and dashboards

• Easy to integrate through open APIs

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