Remote Study Management & Remote Monitoring for Clinical Trials

What is Remote Study Management?

The rise of virtual, remote and decentralized clinical trial models are disrupting the traditional approach to study management. More team members are working remotely, and having a secure, collaborative tool for study management is critical. Limitations on travel and on-site visits to medical sites has made remote and virtual monitoring a necessity. SimpleTrials CTMS, with integrated monitoring module and eTMF, provides a secure, web-based, study management suite for your remote clinical team.

What is Remote Monitoring?

Remote monitoring is the process of reviewing and reporting on the conduct and progress of a site participating in a clinical investigation, while not being physically present at the site. The FDA has recognized disruptions to on-site monitoring, and has recommended phone and video alternatives. While making it more difficult to perform physical inspection of facilities and documentation, remote monitoring has a number of benefits. Whether on-site or remote, the visit report documents the visit. Here are some of the common sections of a visit report:

  • Visit Overview

  • Action Items

  • Study Documents Review

  • Subject Screening and Enrollment Status

  • Subject Consent and Data Review

  • Serious Adverse Events Review

  • IP Review

  • Protocol Deviations

  • General Comments

  • Attachments

Designed by clinical trial experts, SimpleTrials bridges every part of your trial management to help make them simple, efficient and compliant.

SimpleTrials is the Easy-To-Use, Collaborative, Flexible CTMS & eTMF Solution

Remote Monitoring Visit Reports

  • Within one study, manage both remote and on site visits.
  • The multi-study calendar provides quick visit oversight.
  • Full eVisit Report workflow, including authoring, revision, and approval.

Custom Visit Report Templates

  • Easy to use report template builder.
  • Templates are fully customizable for remote and on-site visits.
  • Action Items and Protocol Deviations roll-up from all visit reports to an aggregated view for quick & easy oversight.
 

Study Management Oversight

  • Real-time data for remote decision making.
  • Dashboards provide visualization of key metrics, including data points for risk based monitoring.
  • Custom CTMS Reports put a wealth of data at your fingertips.

Simple, Well Organized eTMF

  • Build your folder structure using the DIA reference model or a simplified custom model.
  • Collect essential documents via upload or email attachment.
  • Track missing documents in app and via reports.
  • Perform QC and get alerted for expired documents.

Secure and Compliant

  • Online collaboration for your local and global users, in a fully validated system.
  • 21 CFR Part 11 compliant, with electronic signatures and full audit trail.
  • User account controls with multi-factor authentication avilable.

Learn More

Example of Charts from the SimpleTrials Study Dashboard

Find out more about managing virtual studies with ease.