Regulatory compliance and audit preparation using RBQM technology

In my last blog, I explained what the ICH guidelines mean for clinical trials in our current environment. In previous blogs, technology came into focus. How do you combine the two when it looks like oil and vinegar? What if you know and understand the ICH guideline but don’t have the technology to support it? Or do you have technical support from RBQM subject matter experts?

The ability to build a system that complies with ICH guidance requires a great deal of patience and knowledge. Understanding the RBQM process doesn’t take effort, nor does it take trial and error and years to get it right. Start with an IT team with extensive IT experience and a flexible and open mind. Make sure you use RBQM subject matter experts who have hands-on experience running risk-based approach clinical trials and strong regulatory knowledge. Sounds easy, right?

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

What if you don’t have the resources to build your own system? Plain and simple, buy options! You may be asking yourself, “What should I be looking for or what qualities should my system have?” The following list will help you ensure that the technology you choose will provide the data quality, subject safety, and design quality required by regulatory guidelines:

  • Designed with user experience in mind
  • Deploy a single solution for risk and monitoring with integrated capabilities that meet regulatory requirements
  • Experience-driven automated therapy area/indication risk planning to improve protocol de-risking processes
  • Integration of risk plans into downstream project operations plans
  • Automatic filing to eTMF
  • Ecosystem agnostic, able to integrate with any system and any type of data
  • Automatic daily data ingest (near real-time)
  • Flexible monitoring
  • Smart Workflow
  • Technology that delivers meaningful data, insights and results
  • Automate risks into alerts while allowing exploratory analysis
  • Compound risks to quickly identify at-risk sites

So you find a company that says they have all these processes built into their system, and you’re excited to see their demo! What questions do you need to ask companies when reviewing their systems? Ask them to show you how the system navigates and executes the list above. Demonstrate their ability to perform any project monitoring needs in a dynamic, user-friendly, regulatory compliant, flexible environment, all systems implemented in a go-type fashion. Make a feasibility list and write down the pros and cons. The system should be able to meet any project monitoring needs. Therefore, the requirement to conduct trials with a risk-based quality management approach is met by regulatory definitions.

Intuitive, intelligent, interoperable, and scalable system that saves costs, improves quality, and applies directions to real-world testing needs. It can be used standalone or in the FSP model. are you ready? We have it ready for you!

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