EDC

Cloudbyz Electronic Data Capture (EDC) is a user-friendly, cloud-based solution built on the Salesforce platform, designed to capture and manage clinical data effectively throughout the entire life cycle of a clinical trial. It enables clinical research teams to efficiently collect, analyze, and manage clinical data of varying complexity and scale, using a point-and-click interface that allows users to build forms and navigate data collection and analysis screens with ease.

Cloudbyz EDC is suited for sponsors, CROs, and clinical research sites seeking to reduce redundancies, enhance data quality, and accelerate study timelines. The platform is HIPAA, 21 CFR Part 11, and GDPR compliant, and is ISO 9001:2015 and ISO 27001:2022 certified, ensuring comprehensive data security and regulatory adherence.

Rapid Study Setup and eCRF Form Library

• Go live with studies faster by creating simple to complex forms and reusable form libraries.
• Cloud-based, easy-to-use interface supports rapid study build, efficient data collection, data monitoring, and data cleansing.
• Decreases efforts and costs involved in the data management process.

Rules Engine

• Create complex forms and set up multiple validation rules at the field level.
• Define data validation checks and validation messages using the Cloudbyz Rules Engine.
• Rule builder enables users to define expressions executed for data validation checks.
• Assign actions to stop users from entering incorrect data, raise queries, and send notifications to appropriate roles for soft validations.

Subject Management

• Track enrollment at site, country, and study levels.
• Create study arms and visit schedules at the study level and apply them to enrolled subjects.
• View a visit calendar to track upcoming subject visits.

Visit Management

• Define procedures, subject visits, and payment policies based on budgets and protocols.
• Calculate projected visit windows according to visit plans and schedule calendars automatically.

eConsent

• Replaces paper-based informed consent documents with interactive, multimedia-enabled, template-driven informed consent on mobile devices.
• Fully integrated with Cloudbyz EDC, enabling real-time visibility and central tracking of enrollment metrics across sites.

Randomization

• Flexible and scalable randomization solution to meet the unique requirements of each study.
• Handles simple to complex randomization schemes with support for stratifications and multi-arm studies.
• Supports Simple Randomization, Block Randomization, and Permuted Block Randomization (Stratified Block Randomization).
• Pre-integrated with the EDC module to help maintain balance between treatment groups.
• Statisticians can generate randomization schedules by defining parameters in a schedule generator form — no coding required.

eCRF (Electronic Case Report Form)

• Cloud-based, easy-to-use solution enabling rapid data collection and more efficient data cleaning.
• Built on the Salesforce platform and 21 CFR Part 11 compliant.
• Features include data back-up, multi-language support, access control, data encryption, multimedia content support, and customizability.

eCOA, ePRO, and eDiary

• Captures clinical outcome data through easy-to-use interfaces, including ePROs, clinician-reported outcomes, and eDiary functionalities.
• Device-friendly and supports time-sensitive data collection.
• Enables upload of multimedia content for patient education and uses edit checks to minimize data errors.
• Supports patient reminders and notifications to maximize data collection rates.

Adverse Event (AE) and Protocol Deviation (PD) Data Capture

• Capture, monitor, track, and report safety events and protocol deviations in real time.
• Supports better risk management and response planning.

Risk-Based Monitoring

• Identify data discrepancies through 100% Source Data Verification (SDV) or set algorithms to perform SDV on specific and relevant data items such as safety data or primary/secondary objectives.
• Easily set up edit checks and risk-based monitoring workflows including Key Risk Indicators, triggers, and thresholds.

Investigator Portal

• Provides a single platform to deliver content and services to clinical research sites.
• Sites can complete eCRFs, report protocol deviations and adverse events, and maintain the Electronic Investigator Site File (eISF).
• Access study information, collect essential documentation, perform investigational product accountability, and communicate with monitors, CROs, sponsors, and other vendors — all from one location.

Patient Portal

• Seamlessly integrates with the EDC solution for ePRO, eConsent, patient information sheets, patient education, eBooks, lab reports, and screening results.

Adjudication

• Facilitates management of endpoint adjudication and reduces variability of results.
• Eliminates or reduces bias, enhances consistency, and improves accuracy of results through automated adjudication.

CDISC Compliance

• Provides end-to-end eCRF configuration and workflows based on CDISC standards.
• Supports CDISC data import and export, full CDISC ODM, and PDF archiving.
• Enables adherence to global regulatory standards.

Query Management and Source Data Verification (SDV)

• Automated query generation and system edit checks.
• Supports 100% or partial SDV capability.
• Real-time notifications, custom dashboards, and reports for query tracking and metrics.

Medical Coding

• Code Medical History, Adverse Events, and Concomitant Medications using standard dictionaries including MedDRA and WHODRUG.
• Ensures faster time to regulatory submission.

Reports, Dashboards, and Data Export

• Ready-to-use and customizable reports and dashboards to track various metrics.
• Create reports with point-and-click configuration to track enrollment numbers, protocol deviations, adverse events, queries, and more.
• Generate annotated CRFs with ease for regulatory submissions.
• Ability to export data in various formats.

Integrations

• Integrates with the Cloudbyz Patient Recruitment solution for end-to-end remote patient recruitment, including study listing, pre-screening, eligibility testing, and appointment scheduling.
• Integrates with Cloudbyz CTMS, eTMF, Budgets and Payments for end-to-end clinical trial project management, including site feasibility, monitoring, IRB approval tracking, and real-time performance tracking.
• Integrates with Cloudbyz Safety and Pharmacovigilance software for advanced analytics, data integrity, and proactive pharmacovigilance.
• Supports patient data extraction via integration with third-party applications and wearable medical devices through APIs.
• Integrates with Electronic Medical Record (EMR) and Electronic Health Record (EHR) systems to populate eCRFs directly, saving significant time and effort for sites.