TRI Risk-Based Quality Management RBQM software technology for risk assessment, risk management and central monitoring


Services - because successfully implementing RBQM is trickier than it looks

RBQM solutions can be difficult to implement because they impact every area of your business. From Standard Operating Procedures to staff hiring, training and retention; from your business model to your IT systems integration. We've helped dozens of companies successfully implement their RBQM solutions. Find out how we can help you.

We're the Risk-Based Quality Management experts because we only do one thing -
RBQM solutions

The 3 big benefits of RBQM are better data quality, increased patient safety, and reduced monitoring costs. But implementing RBQM solutions can be hard. Developing in-house tools, training and processes is time-consuming and expensive. And there's a shortage of trained and experienced people.
Let us help speed things up so that you get to the benefits faster.

Tools

Support to identify your gaps and get you up and running quickly.

Gap

Analysis

Compliance

Pack

Training

Quick, easy, effective

e-learning modules for all your staff.

Good Clinical

Practice

Risk Assessment

& Controls

Consultancy

Learn from Operational experts to develop your own skills.

Protocol Risk Assessments

Integrated Strategic Monitoring Plans

Gap Analysis

Our 6-step process identifies the gaps in your current documentation, tools and processes. The impact analysis highlights priorities for compliance. We then make recommendations for change, giving you a very clear plan for implementing RBQM.

20211207 Gap Analysis slide.PNG
 
Compliance Pack
20211208 300 x 200 Artboard 1-20.jpg

A suite of documents and templates ready to customize for your organization, including SOPs (e.g. Risk Assessment & Management; and Clinical Quality Oversight), templates (e.g. Integrated Data Monitoring Plan), and job specifications (e.g. Central Monitor).

Good Clinical Practice e-learning

Quick to deploy, easy to use, fun to learn. This e-learning module takes your staff through the key GCP principles, identifies key roles and explains the importance of RBQM in clinical trials.

 
Risk Assessment & Controls e-learning

This e-learning module takes you through the importance of risk management in clinical trials, including how to identify and evaluate risks, and what to consider in risk controls. Learners are tested to ensure they've understood the content, and given a certificate on passing the course.

 
Integrated Strategic Monitoring Plans

ISMPs are the critical link between your Protocol Risk Assessment and successful Central, Remote and Site Monitoring. Get in touch to find out how they work and the 10 key elements to making cross-functional ISMPs effective and efficient. 

TRI Team working with sponsor and CRO on ICH E6 (R2) RBQM RBM Integated Strategic Monitoring Plan for Clinical Trial Study Risk Based Monitoring Risk-Based Quality Management
Protocol Risk Assessments

Good Protocol Risk Assessments are fundamental for high quality clinical trials. Correctly identifying critical variables up front, creating risk statements and then evaluating likelihood, impact and detectability are all vital skills.

TRI team working with sponsor and CRO clients on RBQM RBM Clinical Trial Study Protocol Risk Assessment ICH E6 (R2) Risk Based Monitoring Risk-Based Quality Management