The first fully integrated monitor visit assessment tool that utilizes the information from the monitor visit report to: score and assess site performance, assess site and study risks, provide corrective action plans (CAPA) based on site assessment scores and perform trend analysis at site, regional and study levels.
|Risk-Based Tool Components||IRMA™ Model|
|Ability to Perform Study Level Risk Assessments|
|Ability to Perform Site Level Performance and Risk Assessments|
|Ability to Focus on Critical Study Parameters|
|Ability to Review Risk Trends at the Site and/or Study Levels|
|Provides Mitigation & Corrective Action Plans|
|References Global Regulations: ICH/GCP, FDA CFR, EU Directives|
|Assists in Identifying Protocol & Regulatory Non-compliance’s|
|Risk-based Monitoring Report – Tailored to Study|
|Identifies Remote and On-site Monitoring Requirements|
|Ability to identify and focus monitor site visits based on actual risk scores achieved for Particular area(s) of the monitor report.|
|Incorporates IRMAs Risk-Based Monitoring Plan|
It makes sense to utilize IRMATM to promote early
identification and continuous assessment of clinical site
areas of risk and improvement.
Key features of Monitor Visit Risk Assessment Tool
Incorporates FDA recommendations for components of the Risk-Based Monitoring Plan and can be incorporated into a company monitoring plan template or used as a stand-alone monitoring plan.
Available at the Study and/or Site levels. Serves as a master risk management document for the study manager and clinical research associate (CRA).
Available at the Study and/or Site levels. Captures and provides graphic details of Study and/or Site risks identified for an assessment or as identified over several assessments allowing for trend analysis of both Study and/or Site level risks.
Is an intelligent monitor visit report that serves as a visit report, educational tool, training tool, regulatory reference tool, risk assessment tool and corrective action plan tool all in one.
Centralized and Triggered Monitoring
IRMA’s ability to tell the monitor when on-site and/or remote monitoring can occur combined with identifying which data to review/verify, allows the CRA to focus on critical areas of risk, saving on Monitoring time and costs related to monitoring activities for areas of low or non-critical risk.
On-site & Remote monitoring activities are determined by the sites’ average risk score
Source document review and verification (SDR/SDV) can be focused on report sections that indicate site risk
Each risk assessment is assigned a score of 0 to 5 (0 represents no risk; 5 represents severe risk).
Each score is color coded to quickly identify site risk.
We will schedule a interactive demo with your team