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Electronic Data Capture
Cloudbyz EDC is a user-friendly, cloud-based solution that is designed to capture 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 enables rapid study build with point and click with an interface that helps users build forms and easily navigate to the appropriate screens for data collection and analysis.
Product Features
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Rapid Study Setup & eCRF Form Library
Rapid Study Setup & eCRF Form Library
With Cloudbyz EDC solution, go live with your studies faster and with ease by creating simple to complex forms and reusable form libraries. A cloud-based, easy-to-use solution that enables rapid study build, efficient data collection, data monitoring and data cleansing. Decrease efforts and costs involved in the data management process.
Rules Engine
Our robust rules engine allows you to create complex forms and set up multiple validation rules at the field level.
Define data validation checks and validation messages, using Cloudbyz Rules Engine. Cloudbyz rule builder will enable users to define the expression that will be executed to be true for data validation checks. Assign actions such as stopping the user from entering the wrong data but making the system raise queries and send notifications to the appropriate roles in the case of soft validations
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.
Randomization
Cloudbyz Randomization solution is flexible and scalable to meet the unique requirements of each study. Effortlessly handle simple to complex randomization schemes with provision for stratifications and multi arm studies. Cloudbyz Randomization module supports and uses its own algorithms for all the randomization types such as Simple Randomization, Block Randomization, Permuted Block Randomization (Stratified Block Randomization)
Comes pre-integrated with the EDC, Cloudbyz Randomization module helps studies maintain balance between treatment groups among subjects they recruit, it is easy for statisticians to generate the randomization schedule by just defining the parameters from a schedule generator form. The schedule is generated automatically without requiring any coding.
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.
eCOA/ePRO/eDiary
Cloudbyz eCOA solution leverages innovative technologies to capture the clinical-outcome data through easy to use interfaces. This includes ePROs, clinician reported outcomes and eDiary functionalities. Our solution is 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. Set up patient reminders and notifications to collect close to 100% data from patients.
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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.
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.
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.
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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 HIPPA and 21 CFR Part 11 compliant to ensure data security.
