Description
MyRBQM Portal allows clinical study teams to identify and categorize risks and assess and mitigate them within the same user-friendly coworking space.
MyRBQM’s built-in intelligence assists in risk identification and mitigation processes by prompting the portal users for potential risks and mitigation actions. New and modified entries are then added to the self-learning library. This automated feature will help study teams save time and effort when setting up the following study. In addition, MyRBQM Portal offers flexible and customizable risk-assessment questionnaires and supports multi-device usage.
Today over 180 clinical research companies use Cyntegrity’s intelligent MyRBQM® technology and services every day to timely detect, combat and prevent risk: “Over the past year, we have been using Cyntegrity’s risk assessment solution for six of our Oncology projects. By using Cyntegrity’s RBQM solution we were able to prospectively identify issues, which allowed us to adapt, optimize and adjust our monitoring activities effectively.” – Bianca Karle, National Research Quality Lead at GenesisCare. Read our customer stories.
MyRBQM® Portal – Features at a Glance
- Customizable TransCelerate RACTs
- Indication-focused RACTs; Oncology, Heart Failure, Diabetes, Pulmonology, Medical Devices, etc.
- Paperless audit trail
- Export to Excel
- Customizable risk questionnaires
- Multi-user communication and collaboration
- Knowledge-library of risks
- Mitigation actions management
- [NEW] Centralized Statistical Monitoring (CSM)
- [NEW] Automated Issue Management System
Additional features for enterprise users only:
- Premium CSM algorithms
- Key Risk Indicators and Quality Tolerance Limits
- Access to the powerful KRI Wiki engine
- Data connection to EDC, CTMS, PV, Lab Data
- Site risk profiles for Adaptive Monitoring (AM)
- Intra/inter-study comparison
- Subject Profiles module
- Predictive Analytics
- Vendor (CRO) Oversight capabilities
NEW: Healthy Volunteers – Phase 1 RACT is specifically tailored to the needs of bio-pharma companies and CROs that run Phase 1 studies. This indication-focused RACT catalog enables Phase 1 study teams to generate risk management plans faster and easier and be well-positioned for study audits.
MyRBQM Portal is thoroughly validated for clinical trials and is 21 CFR part 11 compliant.
