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Electronic Data Capture
Cloudbyz EDC is a user-friendly, cloud-based solution that is designed to store and manage clinical data effectively throughout a clinical trial’s life cycle. Our innovative solution enables the 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.
Product Features
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eConsent
Cloudbyz eConsent replaces the paper-based informed consent document with interactive, multimedia enabled, and template-driven informed consent on mobile devices. The solution is fully integrated with Cloudbyz EDC enabling real time visibility and central tracking of enrollment metrics across the sites.
RTSM
Cloudbyz Randomization & Trial Supply Management (RTSM) solution is totally customizable per the requirements of a clinical study. Our system uses an integrated IWRS (Interactive Web Response System) and effortlessly handles simple to complex randomization schemes with provision for stratifications and multi arm studies. The system has the ability to perform all the tasks related to trial supply management such as Investigational Product Accountability, centralized inventory tracking, threshold management, automated orders and notifications.
eCRF
Cloudbyz eCRF (electronic case report form) is a cloud-based, easy-to-use solution that enables rapid data collection, more efficient data cleaning and an overall decrease in the efforts and costs involved in the data management process. Our solution, built on the Salesforce platform, is 21 CFR part 11 compliant and has features such as data back-up, multi-language abilities, security features such as access control and data encryption, multimedia content support and customizability.
ePRO/eCOA
Cloudbyz eCOA (Electronic Clinical Outcome Assessment) solution engages innovative technologies to capture the clinical-outcome data. This includes ePROs (electronic patient reported outcomes), performance outcomes, clinician reported outcomes and eDiary functionalities. Our solution is handheld device friendly, supports time-sensitive data collection, enables upload of multimedia content for better patient education, and uses various edit checks to minimize data errors.
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Risk Based Monitoring
Identify data discrepancies through 100% SDV or set algorithms to perform SDV on specific and relevant data items such safety data, primary or secondary objectives etc. Easily set up edit checks within the system and risk-based monitoring workflows including Key Risk Indicators, triggers and thresholds.
Query Management
Query Management
Cloudbyz Query Management solutions provide efficient communication between monitors, data managers and coordinators. Features include automated query generation, posting the queries into the EDC system, real-time notifications, review of site responses, reissuing/closing of the queries and generation of custom dashboards and reports for query tracking and metrics.
Investigator Portal
Cloudbyz Investigator Portal solution provides a single platform to deliver content and services to clinical research sites. With investigator portal, sites can complete eCRFs, report protocol deviations and adverse events, maintain eISF (Electronic investigator Site File), access study information, collect essential documentation, perform investigation product accountability, and communicate with monitors, CROs, Sponsors and other vendors, all from single location.
Integrated with Patient Recruitment
Cloudbyz EDC solution can be easily integrated with our patient recruitment solution which delivers end-to-end remote patient recruitment. The solution offers features such as study listing, patient portal, pre-screening, templates, eligibility testing and appointment scheduling.
Integrated with CTMS, eTMF, Budgets & Payments
Cloudbyz DCT solution offers end-to-end project management of the clinical trials. It supports in-depth site feasibility study, monitoring, study management, IRB approval tracking, training, real-time performance tracking, among others. The Cloudbyz EDC can be integrated to the CTMS for easy extraction of data directly on to the specified fields of the eCRFs.
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Integrated with Safety & Pharmacovigilance
Our EDC solutions easily integrate with our centralized cloud-based pharmacovigilance software solution for advanced analytics set-up along with data integrity. It empowers the end-user with proactive pharmacovigilance, smart features with data-backed predictability, scalability and cost-effective support.
EHR & EMR Integrations
The cloudbyz EDC platform allows easy integration with various Electronic Medical Record (EMR) and Electronic Health Records (EHR) systems to populate the eCRFs directly and save huge amounts of time and effort for the sites. Our system is comprehensive, safe, secure and is HIPAA and 21 CFR Part 11 compliant to ensure data security.
