CS- RMS

Remote Monitoring System

CS Clinical Trial Remote Monitoring Systems (RMS) is a web based & easy-to-use software which enables companies to perform remote Source Data Verification (rSDV) / remote Source Data Review (rSDR) without having monitors travelling to the sites.

 

Clinevo Remote Monitoring System for Clinical trials - meets regulatory guidelines including :

  • Redacting personal / sensitive information,

  • Version control,

  • Security and access control, 

  • Change controls,  

  • Digital content archiving,  

  • Audit trails, and 

  • System validation. 

Monitor and Track

Monitor the completeness, Quality, and Timelines of the QC/rSDV/rSDR process

Feedback / Workflow

system moves the documents back to sites with notifications to next workflow with monitors’ feedback

QC/rSDV/rSDR

Centralised team / Monitors perform Quality Check / Source data Verification / Source Date Review

Remote Monitoring Plan

Plan the study / Subjects Visits, Milestone dates etc. Create site Users and Central monitors in the system

Sites and Source Documents

Site teams uploads redacted copies of trial related source documents into the system

Notifications to Monitors

Central monitors / CRA gets the review / QC notifications as and when sites upload new source documents for a subject / visit

REDACTION OF INFORMATION

  • System provides options to redact sensitive information from the site / patient / visit documents.

 

SHARING AND COLLABORATION

  • Clinical Trial Remote Monitoring Software allows users to invite external parties to upload and work collaboratively on documents in a controlled method

 

FASTER USER ADOPTION

  • Site personnel, Monitors and others can be trained on Remote Monitoring System for Clinical Trials within few hours for remote Source Data Verification (rSDV) / remote Source Data Review

 

ANYTIME, ANYWHERE & ANY DEVICE

  • User-friendly web application can be accessed with internet / intranet using IE, Chrome and Firefox browsers and on any device which enables real-time site collaboration and document exchange

REGULATORY INSPECTION READY

  • Clinical Trial Remote Monitoring Software complies with DIA, 21 CFR Part 11, ANNEX 11, GxP and GDPR guidelines for enabling remote Source Data Verification (rSDV) / remote Source Data Review

 

EXTENDABLE DOCUMENT MANAGEMENT

  • System can be used as a focused clinical trial Remote Monitoring software for remote Source Data Verification (rSDV) or as general document management system for a clinical trial

LIVE TRACKING & STATUSES

  • Based on the file plan, the Clinical Trial Remote monitoring software tracks the remote Source Data Verification (rSDV) status at every level of a clinical trial

 

CONFIGURABLE SOURCE DATA VERIFICATION  

  • Remote Monitoring System for Clinical Trials (RMS) ships with a pre-built reference model & also allows organizations to define their own / Study / Site/ Patient specific references for remote Source Data Verification (rSDV)

 

FILE PLANNING & MILESTONES SETUP

  • The Remote Monitoring System for Clinical Trials allows companies to create File Plan , milestones and placeholders at the Study / Site / Patient / Visit level for remote Source Data Verification (rSDV)

 

DOCUMENT LIFECYCLE AND VERSION CONTROL

  • Clinical Trial Remote Monitoring Software (RMS) has a robust document life cycle with Author, Review, eSign/Approval workflow & Automated version controlling with robust Check-in and Check-out functionality for managing remote Source Data Verification (rSDV) and remote Source Data Review processes

 

ADVANCED ANALYTICS

  • Remote Monitoring System for Clinical Trials (RMS) provides advanced analytics to track Completeness, Quality, Timeliness and Source Data Verification (SDV) compliance of a clinical trial.

 

BULK / QUICK UPLOAD

  • Clinical Trial Remote Monitoring software allows users to upload hundreds of documents in one go using a simple drag and drop & provides dynamic indexing options for documents