RBQM Ops 2022 - What does a good Risk Assessment look like?

What does a good Risk Assessment look like?

SUMMARY KEYWORDS
organisation, risk assessment, patient, monitoring, study, site, quality management, risk-based, teams, number, data, clinical trials, protocol, support, risk, conduct, data entry, process, treatment, early phase

DUNCAN HALL:

I'm really excited to introduce our next speaker, Kimberly Lodge-Maragh. Kimberly is the manager of clinical risk at Alimentiv. And I'm excited because I know from first-hand experience the extraordinary RBQM journey that Alimentiv have been on over the last five years. They haven't just implemented RBQM they've really embraced it, right from the CEO, Jeff Smith, down to those people who are actually performing risk assessments and central monitoring on a daily basis. Their RBQM capability is one of the many things that makes Alimentiv an absolute authority on GI disease.

Now, today, Kim is going to be talking about what good risk assessment looks like and sharing some of her insights. So Kim, thank you over to you.

KIM LODGE-MARAGH:

Thank you so much for the warm introduction. Good morning. Good afternoon, everyone. As Duncan mentioned, my name is Kim Lodge-Maragh, and I am the manager of clinical risk at Alimentiv. Just a little bit more about Alimentiv. We are a GI focused CRO that provides a broad range of Clinical Research Services to pharmaceutical and biotech companies, as well as academic investigators. Forte, it is our RBQM programme here at Alimentiv. And really, we are dedicated to transforming human health and the future of Gi research. And we do this by working to minimise risk throughout all stages of clinical trials. I'm very pleased to speak to you today on the topic. What does a good risk assessment look like?

This first slide is my disclaimer. In short, the views and opinions that are expressed today in this presentation and any accompanying slides are mine and should not be attributed to Alimentiv, TRI and or its affiliates.

As Duncan mentioned, our RBQM journey began several years ago. Our adoption and implementation focused on four main components which you can see on the screen. Culture, people, process, and tools.

Culture, in my opinion, is the single most important adoption component. This includes a degree of awareness and support across the organisation. From the very beginning of our RBQM journey, we received support at the senior leadership level. This then led to the creation of a core and expanded group of cross functional team members who really worked to bring about the adoption and embed this framework into our organisation. With the introduction of our RBQM program or Forte, there came a need for new roles that would provide expertise and risk management and support our portfolio and project teams with the associated risk management activities...