eRegulatory

Manage essential trial documents, stay inspection ready, and collaborate real-time with study partners.

TRUSTED BY

eRegulatory

Cloudbyz eRegulatory solution offers a cloud-based repository for all of your clinical trial documents. Digitally capture, manage, share, and store all clinical trial-related documents with a centralized overview. Manage essential trial documents, stay inspection ready, and enable real-time visibility for CROs, sponsors, monitors, and other stakeholders in a clinical trial.

With Cloudbyz eRegulatory, research sites can streamline regulatory workflows with paperless binders and an electronic delegation log.

Product Features

Click to Enlarge

Centralized File Management

Cloudbyz eRegulatory solution enables sites to manage common files such as CVs, Medical Licenses, Credentialing certifications, training logs, etc in a centralized location and automatically align common documents to study as soon as study setup is complete.

Click to Enlarge

Drag & Drop Upload

The drag & drop functionality in the eRegulatory ensures flexibility with easy movement of one or more files for uploading in the desired electronic trial master file folder.

Click to Enlarge

Generate Document

It facilitates easy document generation in CTMS such as site green light process, protocol deviation, adverse events and trip reports and save to eRegulatory by click of button.

Click to Enlarge

Digital Site Binder Management

Cloudbyz eRegulatory solution comes with template-based and configurable site binder structures. The solution supports the DIA Reference Model for eISF in addition to custom folder structure based on the study and client needs.

Click to Enlarge

Electronic DOA

Cloudbyz eRegulatory solution comes with automatic generation of electronic delegation of authority log (eDOA) based on the team roles and assigned responsibilities. The study team can sign on the eDOA log through inbuilt electronic signatures. The log can be maintained live for the entire duration of study and can be generated for filing into the site binder and/or the eTMF.

Click to Enlarge

Training Tracker

Cloudbyz eRegulatory tracks training logs for all site staff involved in clinical study. The training log can be routed for electronic Signature and be saved in the regulatory.

Click to Enlarge

Remote Access

Cloudbyz eRegulatory comes with portal capabilities where external stakeholders can login to review real-time updates and access regulatory documents. With permission enabled, Sponsors and CROs can download regulatory documents and save them in their eTMF system.

Click to Enlarge

eSignatures

The Cloudbyz eRegulatory solution supports 21 CFR part 11 compliant eSignature capabilities.

Click to Enlarge

Approvals

Cloudbyz eRegulatory comes with point and click and drag and drop configurable workflow and approval process engine which enables customers to configure their own approval process and workflow automation.

Click to Enlarge

Integrated with eSource

Cloudbyz eRegulatory solution is integrated with eSource, CTMS and Patient Recruitment capabilities and enables seamless collaboration across teams and helps to achieve efficiency.

Key Benefits

Cloudbyz eRegulatory is built 100% native on the leading Salesforce platform and comes with deep clinical research eSource capabilities.

Configurable

Cloudbyz eRegulatory solution is easily configurable with point- and click and drag &drop capabilities to create forms, workflows, alerts, validations, automations, and more.

Scalable

Cloudbyz eRegulatory auto scales to meet high volume studies without impacting performance. Cloudbyz eSource is able to scale to support global site networks.

Compliance

The Cloudbyz eRegulatory solution is built on the Salesforce platform which meets industry regulatory requirements including SOC1, SOC2, SOC3, HITRUST, HIPAA, GDPR, ISO 27001, and many more. Cloudbyz also provides additional compliance such as 21 CFR Part 11, ISO 9001, GCP, Gamp5, and more.

Workflow Automation

Cloudbyz eRegulatory solution comes with configurable workflows, processes, user flows, and validation configurations. With user-friendly configuration, customers are in control to tailor the solution to meet their specific needs.

Real-time Collaboration

The Cloudbyz eRegulatory solution provides integrated capabilities across the clinical trial process enabling end-to-end collaboration across business units. In addition, external portals allow, customers to invite external stakeholders such as patients, sponsors, CROs and IRBs to collaborate in real time. Granular permissions allow admins to control what information gets accessed to ensure data privacy and integrity are maintained.

Reports & Dashboards

Cloudbyz eRegulatory solutions comes with easy to create reports and dashboards using simple point-and-click configurations. Reports can be exported in various formats and subscribed to via email.

Open APIs

The Cloudbyz eRegulatory solution built on the Salesforce platform comes with open APIs and supports web services via SOAP APIs, REST APIs, and more to enable real-time integration with external systems such as Sponsor or CRO EDC systems, medical devices, EMR/EHR systems, financial systems, and any application with open APIs.

Customizable

The Cloudbyz eRegulatory solution can also be extended with additional capabilities to meet special needs by the customers using lightning web components.

eRegulatory

Manage essential trial documents, stay inspection ready, and collaborate real-time with study partners.

eRegulatory