Risk-Based Monitoring (RBM), Quality by Design (QbD), eClinical (RBM) Process Development
- The Food and Drug Administration, European Medicines Agency, and the International Council on Harmonization have put an increased focus on implementing Quality by Design principles in the oversight of Clinical trials. Quality by Design has been an accepted approach for improving trial quality in other industries and even in Pharma/Biotech/and Device manufacturing. Risk-Based Monitoring is a component of Quality by Design principles focused on clinical trial oversight.
- Implementing Risk-Based Monitoring methods require significant changes in processes and changes in eClinical Technology design. MANA has redesigned the clinical trial process including Standard Operating Procedures (SOPs), Work Instructions, Document Templates, and training on the MANA Method for Risk-Based Monitoring and Remote Trial Management.
- MANA offers options to help you learn and implement the Risk-Based Monitoring and Remote Trial Management (MANA Method) or we can design processes specific to your organization’s needs.
Risk-Based Monitoring: Risk Assessment for Protocol Optimization—Risk Assessment is the first, and absolutely critical, step to implementing Quality by Design and Risk-Based Monitoring. The Risk Identification process affects the design of the technology systems, design of visit processes, and development of reports to support oversight of high risk data elements and processes.
There are two components of Risk Assessment.
- Protocol Design Risk Assessment addresses ways to eliminate risk during protocol design. MANA RBM's protocol design services assist you in identifying and eliminating risk.
- MANA RBM provides expert physician input into protocol design. This expertise can be from a therapeutic/treating physician perspective or the perspective of an experienced physician clinical trial specialist. These physician experts help Sponsors optimize assessments, timing, and Inclusion/Exclusion criteria to make recruiting and patient evaluations more successful.
- MANA RBM also provides expert Study Coordinator focus groups to optimize study design. Study Coordinator Focus Groups are a great way to assure successful study conduct at the site level. This practical input can help with protocol development, eSource design, and other study support activities.
Protocol Implementation Risk Assessment: Identifying High-Risk Data Elements and Processes or “What Can Go Wrong?”
Once the protocol has been designed optimally, MANA RBM helps your team identify critical data elements and processes for:
- Subject Safety
- Efficacy Endpoints
- Investigational Product Management
- Good Clinical Practice Compliance
- Protocol Compliance
For each High Risk Data Element or process, we help the team classify the likelihood of occurrence, its impact, and identify any controls in place or that should be developed to identify and manage high risk areas.
MANA RBM works with your team to identify how the team will oversee these elements, who will do the work, and the frequency of the work. These activities are documented in our Data and Document Review Guidelines, a cross-functional tool that defines the review process.
Risk-Based Monitoring: Central Monitoring and Trend Identification
- Our Central Monitoring activity is focused on reviewing site performance in two ways:
- Identify any evidence of fraud or consistent errors across subjects at a site
- Identify outlier sites across a range of quality measures
- MANA RBM can provide Central Monitors to conduct cross-subject and cross-site performance review and Issue management. Our Monitors complete monthly assessments of overall study performance and a report of each site’s performance that is shared with the Principal Investigators. MANA RBM's Central Monitors also manage the Issue Management Process and follow-through to assure issues are identified, mitigated, and resolved.
Risk-Based Monitoring: Site Monitoring using Remote Site Management
- The Site Monitor’s role changes significantly when Source Data Verification is limited/eliminated as the main focus of quality oversight. We provide a unique approach to comprehensive Source Data Review with our Subject Profile Analyzing Risk (SPAR). This proprietary tool enables the monitor to efficiently review all High Risk Data Elements approximately 80% faster than with traditional Electronic Data Capture (EDC) review. SPAR synthesizes data across all data collection tools.
- Site Monitors also learn how to use data, reports, and study metadata to better assess site performance.
- The Site Monitor remains the key contact with the site and is responsible for the majority of the Root Cause Analysis and remediation. They also communicate the Site Progress Report Findings with the Principal Investigator
Risk-Based Monitoring: Issue Management including Root Cause Analysis
- Issue Management is a key component of implementing a Risk-Based Monitoring approach to trial management. It is critical to identify issues, categorize them and define the scope to ensure a learning environment and that quality remains a top priority.
Our team has developed an entire Issue Management Process including the tools (see eClinical Technology) and training.
Risk-Based Monitoring: Remote Investigational Product Oversight
- Investigational Product Oversight is a critical component of Quality Oversight. It is one of the top findings of FDA Site Audits year in and year out. MANA RBM designs systems and processes to enable comprehensive, remote IP management oversight. Onsite Visits can be used to confirm that the data recorded by the Site was accurate.