Learn more about RBQM and ICH E6 (R2)

5 easy ways we can help you and your team get up to speed on RBQM and R2

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1. Free webinars - we run free webinars most weeks and topics include:

   • RBQM - the basics/foundation

   • Critical Data

   • Risk Assessment and Evaluation

   • Risk Controls 

   • Risk Communication/Functional plans

   • Risk Review

   • Centralized Monitoring

   • The RBQM CRA

   • Click to see the latest webinar schedule​

2. Free workshops - half-day workshops with lots of practical, hands-on learning and sharing real-life experiences with industry peers:

   • RBQM Fundamentals​ including Risk Assessment and Critical Data

   • Risk Controls and Integrated Strategic Monitoring Plans

   • Centralized and Risk-Based Management

   • Site Monitoring and the future role of the CRA

   • Find out where and when the next workshops are scheduled

3. E-Learning - GCP training delivered to thousands of users - available on your learning platform or our​s - contact us to find out more - new topics coming soon

4. On-site learning - Our RBQM experts come to you to deliver bespoke training, tailored for your specific challenges - contact us to find out more

5. Remote learning - Bespoke training delivered by webinar for when your team is spread around the world - contact us to find out more

Get ready for compliance

3 quick ways we can help you become R2 compliant

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1. R2 Gap Analysis - Have our expert team identify the gaps in your Quality Management ​processes and Standard Operating Procedures (SOPs) - click here to find out how we do this for you

2. SOP Pack​ - Quickly plug those gaps with our tried and tested SOP, Reporting and Plan templates, including:​

   1. ​Risk Assessment and Management SOP

   2. Central Monitoring SOP

   3. Quality Risk Management Plan Template

   4. QTL Guidance Document

   5. Root Cause Analysis Guidance Document

   6. Clinical Quality Oversight SOP

   7. Central Monitoring Plan Template

   8. Central Monitoring Report Template

   9. Central Monitor Job Description

   10. Find out more about the SOP Pack

3. R2 Services - if you don't have the resources in house to adapt, check and implement the SOP Pack, let us do that for you - ask about this service​

Successful RBQM in practice

2 services to help you successfully implement RBQM

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1. Facilitated Protocol Risk Analysis - Have experienced RBQM professionals facilitate your team in getting your clinical trial off to the right start by bringing years of practical knowledge to identifying critical factors, risks, risk indicators, quality tolerance limits and more - click here to find out how we do this for you

2. Consultancy​ - sometimes you just need specific support, advice, and guidance from experienced people who've been there, done that and got both the battle scars and the T-shirt to prove it.  We're here to help so please just ask.

Automation & Scaling

Our RBQM platform OPRA delivers scalability, consistency, and compliance

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1. OPRA Risk Assessment and Risk Management - The OPRA Risk Assessment and Risk Management is a fully validated tool based on the E6 (R2) Quality Management end-to-end process

   • Watch this video to find out why OPRA RAM is such a great tool to identify and manage your trial risks

   • Ask for an OPRA RAM demo today

2. OPRA Centralized Monitoring​ - OPRA uses statistical modeling and data visualization to allow any member of your team to identify statistical outliers and enable the focusing of resources and early intervention on data quality trends that can make or break a trial. Ask for a demo today

Common RBQM problems

In our surveys, there are 5 problems that come up time and again. If you are struggling with any of them please get in touch. We're sure we can help because we've seen them before :-).

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1. Lack of understanding/awareness

2. Leadership support

3. Lack of time/budget/resource

4. Need for technology

5. Change Management