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:

    • Healthy Volunteers – Phase 1 (NEW)
    • 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)
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

Single User

discover MyRBQM® Portal

from € 148,00 / month
Available seat bundles : single seat
RBQM White Belt online course : not 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)
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

from € 498,00 / month
Available seat bundles : 5 / 15 / 45
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)
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)
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?

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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