Pioneer in Lean Risk-Based Data Analytics

  • User-friendly risk communication and collaboration space dedicated to clinical researchers

  • Proprietary risk detection algorithms designed specifically for bio-pharma

  • Leads Clinical Operations teams to risk-controlled strategies and processes to meet ICH E6 (R2) compliance

  • Facilitates critical process and data identification

  • Drives early risk detection, evaluation, control, communication, review, and reporting

RBQM Portal by Cyntegrity

Turnkey KRI Engine to Combat Clinical Risks at Source

Cyntegrity-MyRBQM-USP-KRIs

  • Consolidates years of clinical research expertise in data quality and statistical data mining

  • Bayesian Inference

  • Statistical Process Control

  • Machine Learning and Statistical Learning / Natural Language Processing

  • Medical Image Analysis and Signal Analysis

Unique Indication Focused RACT Catalogs

  • Built on the original TransCelerate spreadsheet methodology
  • Enhanced with complementary risk mitigation actions

  • Currently available indications:

    • COVID-19 [NEW]
    • Healthy Volunteers – Phase 1
    • Heart Failure
    • Oncology
    • Pulmonology
    • Diabetes
    • Cardiovascular
    • Medical Devices
  • Fully customizable to your specific research needs
@RACK Lib

Regulatory Compliance-by-Design

Cyntegrity-MyRBQM-USP-compliance

  • Full traceability of risk entities

  • Digital, time-stamped audit trail

  • Automated risk probability feedback loops

  • GCP validated

  • CFR 21 Part 11 Compliant

Holistic Risk-based Quality Management

  • All risks are in scope from start to finish

  • Uses EDC, CTMS, IxRS, LabData, PV systems as data sources for KRIs

  • Enhanced statistical significance

  • Easy to view site risk-profiles

  • Drives study cost reduction

Cyntegrity-MyRBQM-USP-Holistic-QM

Get MyRBQM Portal Today

Choose the license that’s right for you

 

 
Available seat bundles
RBQM White Belt online course
Fully GCP validated
Time-stamped audit trail
IQRMP export to Excel
Multi-device support; desktop, tablet, mobile
Customizable TransCelerate RACT
Indication focused RACTs; COVID-19, Healthy Volunteers - Phase 1, Oncology, Diabetes, Pulmonology, Heart Failure, Medical Devices
Mitigation actions libraries
Corporate intelligence management
Automated Issue Management System (IMS); tickets, triggers, alerts, reminders
Centralized Statistical Monitoring (CSM)
KRI Wiki Resource
Additional premium CSM algorithms
Key Risk Indicators and Quality Tolerance Limits
Data connection to EDC, CTMS, PV, Lab Data
Site risk-profiles for Adaptive Monitoring (AM)
Intra/inter-study comparison
Patient Profiles module
Access to KRI Wiki engine
Predictive Analytics
Vendor (CRO) Oversight capabilities

Professional User

great for team collaboration

price on request
Available seat bundles : 5 / 7 / 15
RBQM White Belt online course : with 5 seats and up
Fully GCP validated
Time-stamped audit trail
IQRMP export to Excel
Multi-device support; desktop, tablet, mobile
Customizable TransCelerate RACT
Indication focused RACTs; COVID-19, Healthy Volunteers - Phase 1, Oncology, Diabetes, Pulmonology, Heart Failure, Medical Devices
Mitigation actions libraries
Corporate intelligence management
Automated Issue Management System (IMS); tickets, triggers, alerts, reminders
Centralized Statistical Monitoring (CSM)
KRI Wiki Resource
Additional premium CSM algorithms
Key Risk Indicators and Quality Tolerance Limits
Data connection to EDC, CTMS, PV, Lab Data
Site risk-profiles for Adaptive Monitoring (AM)
Intra/inter-study comparison
Patient Profiles module
Access to KRI Wiki engine
Predictive Analytics
Vendor (CRO) Oversight capabilities

Enterprise User

ideal for scaling-up

price on request
Available seat bundles : unlimited seats
RBQM White Belt online course : included
Fully GCP validated
Time-stamped audit trail
IQRMP export to Excel
Multi-device support; desktop, tablet, mobile
Customizable TransCelerate RACT
Indication focused RACTs; COVID-19, Healthy Volunteers - Phase 1, Oncology, Diabetes, Pulmonology, Heart Failure, Medical Devices
Mitigation actions libraries
Corporate intelligence management
Automated Issue Management System (IMS); tickets, triggers, alerts, reminders
Centralized Statistical Monitoring (CSM)
KRI Wiki Resource
Additional premium CSM algorithms
Key Risk Indicators and Quality Tolerance Limits
Data connection to EDC, CTMS, PV, Lab Data
Site risk-profiles for Adaptive Monitoring (AM)
Intra/inter-study comparison
Patient Profiles module
Access to KRI Wiki engine
Predictive Analytics
Vendor (CRO) Oversight capabilities

Got Questions?

We’ve created a Frequently Asked Questions page to provide clear responses to the questions that are most often asked by our clients and project partners when discussing our MyRBQM Portal.

FAQS

We are There to Help You

No need to mention that we are on standby to help you with any question you may have. If you require more in-depth consultation we can partner with you to provide ongoing support as your extended clinical research department.

CONTACT US

Still Thinking About It?

Why not subscribe to our 30-day free trial and discover MyRBQM Portal’s powerful features at your own time, at your own pace?

YES, SUBSCRIBE FOR FREE

Today over 180 clinical research companies use Cyntegrity’s intelligent MyRBQM technology and services every day to detect, combat and prevent risk: “I used Cyntegrity with my clients and with my students. It’s a great risk assessment tool!” – Moe Alsumidaie, Head of Research at CliniBiz. Read our customer stories.

MyRBQM Portal – Your Gateway to Clinical Success