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CloudByz for Employee Experience <br>Improve Operations

CloudByz for Employee Experience
Improve Operations

Cloudbyz is focused on building an eClinical platform based on cloud which can help customers of all sizes conduct clinical trials efficiently to bring life saving therapies faster to market and improve patient lives.

Step 1 of 10

CTMS- Project and Study Management

Cloudbyz CTMS solution offers end-to-end project management of the clinical trials. Set up and visualize studies according to protocol requirements and easily access details such as phase, type, therapeutic area, indication, outcomes, eligibility, etc. Set up and track protocols and amendments.

CTMS- Project and Study Management CTMS- Project and Study Management

Step 2 of 10

CTMS- Site Management

Manage and engage with sites directly from the system. Assign sites to a particular study and track their documentation, credentialing, equipment, facilities, and activation status. Deliver content and services to clinical research sites through the investigator portal. Provide documents to all the sites through the system to keep the sites informed and engaged.

CTMS- Site Management CTMS- Site Management

Step 3 of 10

CTMS- Site Feasibility

Site Feasibility

CTMS- Site Feasibility CTMS- Site Feasibility

Step 4 of 10

CTMS- Subject Management

Get Real-time visibility to all the subjects and track subject visit activities and schedules. Define the procedures, subject visits & payment policies depending upon the budgets and protocols.

CTMS- Subject Management CTMS- Subject Management

Step 5 of 10

CTMS- Clinical Monitoring

Set up a monitoring schedule based on the monitoring plan and Schedule monitoring visits. Identify data discrepancies through 100% SDV or set algorithms to perform SDV on specific and relevant data items such as safety data, enrollment, 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.

CTMS- Clinical Monitoring CTMS- Clinical Monitoring

Step 6 of 10

eTMF- Standard and Custom TMF reference Models

Use the latest version of the widely used built-in DIA reference model or use your own model. Add or remove folders from the built-in models and apply directly to a study as required by a study-specific TMF plan and index.

eTMF- Standard and Custom TMF reference Models eTMF- Standard and Custom TMF reference Models

Step 7 of 10

eTMF- Full TMF Search

Find and retrieve documents using a search engine that's effective for both file names and metadata. Create custom list views with numerous available filters.

eTMF- Full TMF Search eTMF- Full TMF Search

Step 8 of 10

EDC- 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.

EDC- eConsent EDC- eConsent

Step 9 of 10

EDC- eCRF Form Builder

Cloudbyz EDC simplifies study setup, accelerates data collection with creation of simple to complex forms and reusable form libraries, and reduces data management costs.

EDC- eCRF Form Builder EDC- eCRF Form Builder

Step 10 of 10

Adverse Event Reporting

Cloudbyz Safety and PV solution allows users to report adverse events, track and manage all cases from receipt to closure, and monitor progress. Attached other product screenshots as well.

Adverse Event Reporting Adverse Event Reporting