Cloudbyz offers a suite of cloud-based software solutions for life sciences companies to digitize and manage clinical trials, including CTMS, eTMF, and EDC systems. Built on the Salesforce platform, these solutions streamline research, drug development, and commercialization processes for pharmaceutical, CRO, and medical device organizations.
Funding
Funding not disclosed
Founders
Product
Problem
Life sciences companies face challenges in managing clinical trials due to disparate systems, complex regulatory requirements, and the need for real-time visibility across all trial phases. These inefficiencies can lead to delays, increased costs, and compliance risks.
Solution
Cloudbyz offers a suite of cloud-based, unified eClinical solutions built on the Salesforce platform to streamline and digitize clinical trial management. The platform provides end-to-end capabilities, including CTMS, EDC, eTMF, CTFM, RTSM, and safety and pharmacovigilance modules, enabling real-time visibility and collaboration across study planning, budgeting, start-up, management, and close-out. By unifying these processes, Cloudbyz helps sponsors, CROs, and sites improve operational efficiency, reduce costs, and ensure compliance with regulatory standards such as FDA 21 CFR Part 11, GCP, GAMP5, HIPAA, and EU GDPR. The platform also leverages AI/ML technologies for document redaction, data extraction, and signal detection, further enhancing data quality and decision-making.
Target Audience
Cloudbyz primarily targets pharmaceutical, biotechnology, and medical device companies, as well as CROs, SMOs, and academic research institutions involved in clinical trials.
Features
- Unified Clinical Trial Management Platform: Integrates CTMS, eTMF, EDC, CTFM, RTSM, and Safety & PV into a single platform for streamlined operations.
- Clinical Trial Management System (CTMS): Manages trial operations with real-time visibility across study planning, budgeting, start-up, study management, and close-out.
- Electronic Data Capture (EDC): Captures and manages clinical data effectively throughout a clinical trial's lifecycle, with features like rapid study setup, eCRF form library, and rules engine.
- Electronic Trial Master File (eTMF): Provides a cloud-based repository for all clinical trial documents, ensuring inspection readiness and real-time collaboration.
- Clinical Trial Financial Management (CTFM): Enables accurate financial forecasting, study budget management, and tracking of site budgets and payments.
- Randomization and Trial Supply Management (RTSM): Manages trial supplies, drug dosing, inventory tracking, and complex randomization schemes.
- Safety & Pharmacovigilance (PV): Offers a unified safety view for better decisions and global pharmacovigilance compliance, with automated case intake and AI/ML capabilities.
- ClinicalWave.ai: An AI-ML solution for intelligent source document identification and redaction, including clinRedact AI, clinExtract AI, and clinDICOM AI.
- Project Portfolio Management (PPM): Manages and optimizes clinical project portfolios and resources, supporting Waterfall, Agile, and Hybrid methodologies.
- Integrations: Seamlessly integrates with external systems using open-access REST APIs, EHR & EMR systems, and health devices & wearables.
- Compliance: Built to meet GxP, HIPAA, and global regulatory and industry compliance standards, with audit trail & eSignature capabilities.