CLINICAL TRIAL RISK BASED QUALITY MANAGEMENT SYSTEM (RBQMS)
DATA QUALITY & GOVERNANCE
OUR RISK-BASED QUALITY MANAGEMENT
SYSTEM PROVIDES PROJECT MANAGERS WITH
A SIMPLE ANALYSIS IN A FEW CLICKS
Contract Research Organizations (CROs) must maintain a high level of quality while operating at maximum efficiency. To find the optimal cross-section of these two drivers, having accurate and timely data is key.
Entitech Solutions worked with a CRO in the small and medium-sized businesses (SMB) market segment to produce a cost-effective solution, allowing risk profiles to be established at the inception of a study, and to track risk mitigation strategies during execution.
- Establishment of a risk profile a study inception, with capability to track all risk mitigation strategies for entire course of the study.
- Detailed tracking of each risk mitigation strategy, including connectors to external Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS).
- Data Lake to provide constant analysis of Risk-Based Management (RBM) Key Risk Indicators (KRIs) coming out of EDC and CTMS, within and across all studies.
- Simple, intuitive client interface for KRI visibility.
- Competitive Advantage: CRO can compete on a much larger scale in that they are now able to provide sponsor required RBQMS processes for their studies.
- Simple to use, powerful solution: Key indicators are continuously updated and easily available and accessible to Clinical project managers with just a few clicks.
- Speed, time saved and reduced resource requirements: Staff previously allocated and managed to gather, consolidate, and produce reports and statistics are freed for more critical and valuable work.