The right tools make the job easy. We have all the tools you need to become R2 compliant and successfully implement RBM.
Go-R2 is a comprehensive accelerator package to help organizations reach ICH E6 (R2) compliance in an efficient and cost effective manner. It has been developed for sponsors and CROs looking to quickly achieve R2 compliance and gain from the benefits of quality planning, quality oversight, centralized and risk-based monitoring. Go–R2 addresses this need through a combination of pre-developed assets, consultation and technology derived from our experience of supporting more than 50 companies in preparing for R2.
- eLearning: A suite of eLearning courses which can be consumed through TRIs hosted service or can be imported into your internal LMS. Courses include R2 awareness, GCP for Operations (including R2) and GCP for Sites (including R2).
- R2 Gap Analysis: A comprehensive review of your existing quality management system including SOPs, Working Practices, Templates etc., to identify gaps with the new R2 requirements. Comprehensive report detailing the findings, recommendations and a plan to reach compliance.
- R2 Compliance Package: Through our existing R2 compliance work, we have identified a set of commonly required assets:
- Risk Assessment and Management SOP
- Central Monitoring SOP
- Quality Risk Management Plan Template
- QTL Guidance Document
- Root Cause Analysis Guidance Document
- Clinical Quality Oversight SOP
- Central Monitoring Plan Template
- Central Monitoring Report Template
- Central Monitor Job Description
- Risk Assessment and Root Cause Analysis Training: A practical workshop to cover all aspects of risk assessment and root cause analysis. The workshop can be based on a specific protocol or our training protocol.
- Risk Assessment Tool: TRI has developed a simple but comprehensive tool for the assessment of protocol risk and subsequent quality management planning. The tool builds on the RACT tool developed by Transcelerate and is currently being used across multiple clinical trials.
- OPRA core KRI package: In order to help companies quickly start managing trials in an R2 compliant manner and benefit from the RBM methodology, we have identified a suite of 15 high value, commonly used key risk indicators (KRIs), which are fully validated and build into the OPRA platform. This allows rapid study start up, easy interpretation of data and a full audit trail of quality management activity in order to prove R2 compliance. With pre-built integration with key EDC vendors, study pricing starts at just $2k per month.