eRegulatory

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.

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.

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.

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.

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.

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.

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.

eSignatures

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

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.

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.