Regulatory compliance and audit readiness using RBQM technology

In my last blog, I expounded on what the ICH guidances mean to clinical trials in our current environment. In a former blog, technology held the spotlight. How do you marry the two together when it seems like oil and vinegar? What if you know and understand the ICH guidances but don’t have the tech to support it? Or you have tech support without an RBQM Subject Matter Expert?

The ability to build a system that meets ICH guidance requires much patience and knowledge. Understanding the RBQM process doesn’t need to be overwhelming nor should it take trial and error moments and years of time to get it right. Start with an IT group with strong IT experience and flexible open minds.  Ensure you utilize RBQM Subject Matter Experts with real world experience in running risk based approach clinical trials and who have a strong regulatory knowledge. Sounds simple, right?

If you have the time and money to invest into building a homegrown system…

What can you do if you don’t have the resources to build your own system? Plain and simple, shop for options! And you are probably asking yourself, “What should I be looking for or what qualities should a system have?” Here is a list that will help you ensure the technology you select will provide data quality, subject safety, and quality by design required by the regulatory guidelines:

  • Designed with user experience in mind
  • A single solution to deploy both risks and monitoring with integration capabilities that meet regulatory requirements
  • Experience driven automated therapeutic area/indication risk plans to improve protocol derisking process
  • Risk Plan integrates into downstream project operational plans
  • Automated filing into the eTMF
  • Eco-system agnostic with the ability to integrate with any system and any type of data
  • Automated daily data ingestion (near real time)
  • Flexible monitoring
  • Intelligent workflows
  • Technology that provides meaningful data, insights, and outcomes
  • Automation of risks into alerts while allowing for exploratory analyses
  • Composite risks to quickly identify sites at risk

So, you have found a company that says they have all of these processes built within their system and you are excited to see their demo! What questions do you need to ask the company when reviewing their system? Ask them to show you how the system navigates through and can perform the list above. Prove that they have the capability to perform in a dynamic, user-friendly, regulatory aligned, flexible environment for any project monitoring needs, all systems go-type manner.  Make a checklist for feasibility and write the pros and cons. A system should be able to function for any project monitoring needs. Thus, meeting the requirements for running trials in a risk based quality management approach by regulatory definition.

Intuitive, intelligent, interoperable, and a scalable system that saves costs, improves quality, and applies direction to the real trial needs. It can be used independently or in an FSP model. Are you ready for it? We have it ready for you!

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