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 -
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.
Support to identify your gaps and get you up and running quickly.
Quick, easy, effective
e-learning modules for all your staff.
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.
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.
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.