Clinical Research Management System

A Process Management Tool for the Entire Study Team

The result of a collaborative development process in one of the world’s most demanding research environments, CRMS is more than just a repository for data. It’s a process management tool for  study teams, research programs, and institutions during all phases of research – from budgeting, IRB submission, participant enrollment, data collection, to analysis.

Participant and Protocol Registry

  • = Track protocol status and progress
  • – Track IRB and other regulatory compliance
  • – Document participant consent, eligibility, and enrollment
  • – Manage studies within an institution, department, or research program
  • – Manage multi-site studies
  • – Role and site-based access to data

Protocol Schema and Participant Calendar

– Design participant event schedules for complex multi-arm protocols

– Define repeating patterns (cycles)

– Dynamically update and extend participant calendars by adding predefined or ad hoc events

– Shift participant schedules to account for scheduling delays

– Adjust participant calendars when the protocol changes

– Track participant events via participant and staff calendar views

Financial Management

  • – Medicare coverage analysis
  • – Dynamically generate budgets based on study calendar
  • – Define invoiceable vs. scheduled sponsor costs
  • – Budget for personnel costs
  • – Track and manage changes

Case Report Forms

  • – Design and build forms for studies and programs
  • – – Share forms and questions across studies
  • Apply validations to ensure quality data entry
  • – Define skip and scoring logic
  • – Manage form and item versions
  • – Schedule and track data entry via participant calendar
  • – Schedule repeated measures
  • – Participant Portal for self-report
  • – 21 CFR Part 11-compliant audit trail
  • – Data export

Data Analytics

  • – All participant demographic and forms data automatically loaded into analytics module
  • – Search, explore and visualize data using data tables, bar graphs, pie charts, maps, histograms, and other tools
  • – Combine data visualizations into dashboards
  • – Point-and-click filtering
  • – Study and role-based access to data

Leading By Example

Our clients have great stories, and we love sharing them.

Vet Arts Connect program, The Institute for Integrative Health, Baltimore, MD

Vet Arts Connect, a research initiative led by the Institute for Integrative Health, uses CRMS to study the impact nature and the arts has on veterans struggling with depression, PTSD, traumatic brain injury, and other conditions. Veterans in the study participate in arts and nature activities provided by various partner organizations within the community. These activities include classes and workshops in writing, gardening, performing arts, hiking, visual arts, and fishing. The program uses CRMS to conduct online surveys that ask participants about their experiences before and after participating in the program. Using CRMS data dashboards, a team of researchers evaluates the findings and plans to share their research with other institutions, policymakers, and professionals who are concerned with the health and well-being of our veterans.