13 episodes

Mid-study protocol changes. Regulatory audit demands. Challenging technology integrations…Sound familiar? Today’s clinical trials are certainly more complex and demanding, and ensuring safety while saving time and money is something everyone wants. Too often in clinical development, we get caught up in our own processes and forget that there’s other ways to approach a problem. We know the struggles you have in the Interactive Response Technology (IRT) world and we want to help! Here at Almac Clinical Technologies, we are in a unique position to share some of the best practices we’ve seen from our wide and diverse client base. Join Matt Lowrie, your host for each episode of the Spotlight on IRT podcast, where he will answer your questions, discuss common pain points, and talk to industry leaders to help you drive efficiencies and prevent unnecessary risks.

Spotlight on IRT: Best Practices Matt Lowrie

    • Technology
    • 5.0, 7 Ratings

Mid-study protocol changes. Regulatory audit demands. Challenging technology integrations…Sound familiar? Today’s clinical trials are certainly more complex and demanding, and ensuring safety while saving time and money is something everyone wants. Too often in clinical development, we get caught up in our own processes and forget that there’s other ways to approach a problem. We know the struggles you have in the Interactive Response Technology (IRT) world and we want to help! Here at Almac Clinical Technologies, we are in a unique position to share some of the best practices we’ve seen from our wide and diverse client base. Join Matt Lowrie, your host for each episode of the Spotlight on IRT podcast, where he will answer your questions, discuss common pain points, and talk to industry leaders to help you drive efficiencies and prevent unnecessary risks.

    Checklist to ensure your IRT is inspection ready

    Checklist to ensure your IRT is inspection ready

    One of the most stressful times on every clinical trial is the inevitable Regulatory Inspection. With a little prep, a touch of knowledge, and just a sprinkling of understanding you can have a much easier inspection. We brought the industry leading Consultants from Advarra Consulting in to have a discussion with us on prepping and overall inspection readiness.

      

    • 44 min
    Best Practices for Maintaining a Trial Master File

    Best Practices for Maintaining a Trial Master File

    Inspectors are focusing on the completeness of your trial master file. Ensuring you have all your documents together can be challenging, especially if you are playing catch up at the end of a trial. Our experts partnered back up with the industry leaders at Advarra consulting to make sure you are aware of everything you are going to need for your trial to be prepared.

      

    • 28 min
    Episode 10: Umbrella Trial Designs: How to assess if your current IRT strategy can support them

    Episode 10: Umbrella Trial Designs: How to assess if your current IRT strategy can support them

    There are plenty of ways to reach a goal, one of those ways is stepping under an umbrella for your clinical trial.  When you want to see results, and you don’t quite have all the answers, it may be time to look at utilizing an Umbrella trial, and making sure your IRT can support that flexibility.

     

      

    • 43 min
    Episode 9: Drug Pooling: How to Improve Cost Savings and Minimize Supply Outage

    Episode 9: Drug Pooling: How to Improve Cost Savings and Minimize Supply Outage

    Drug supply is an art form.  We all know drug can be expensive, it can be in short supply, or trial needs can shift based on enrollment. In this episode we discuss the advantages of pooling drug for use across multiple studies and how you can gain advantages, cost savings, and quality.

     

      

    • 39 min
    Episode 8: IRTechnophobia – [noun] Fear of full-service IRT providers

    Episode 8: IRTechnophobia – [noun] Fear of full-service IRT providers

    IRT in a clinical trial is a lot like an oil change. No one wants to pay a lot, some people think they can do it on their own, but at the end of the day, if it goes wrong- everything comes crashing down. In this episode, we discuss why you need to evaluate your provider past just cost and timelines.

    Suggested resources for this topic:

    Latest IRT Systems Accelerate Trial Progress and Support Patient Safety

    Auditing of a Technology Vendor Checklist

      

     

    • 30 min
    Episode 7: To Error is Human, But to Uncover The Root Cause is Divine; An In-Depth Look at IRT Software Investigations

    Episode 7: To Error is Human, But to Uncover The Root Cause is Divine; An In-Depth Look at IRT Software Investigations

    How many ways can you calculate 6? 4+2? 5+1? There are infinite possibilities. When developing software, especially an IRT, anytime you introduce customizations you introduce the chance for an error. Today we are discussing the who, what, when, how, and why errors occur, and what your technology vendor should be looking for if something happens. It’s not just someone making a mistake, and in the technology world there is a lot that goes into an investigation.

     

      

     

    • 54 min

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