IRTSpotlight:Best Practices

Episode 14: Tips for Conducting an Effective Kick Off Meeting

New relationships and projects are always exciting; the thrill of something new, the endless possibilities, and most importantly the potential that you can see. Just like a bad first date can tank a relationship, a rough start to a project can set a poor tone for the duration. In this episode, our experts discuss setting the tone on a project, and how to start off on the right foot when we start together.

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Episode 13: Advantages of Agile Methodology

Software is an ever evolving industry. In the clinical trial world, we’ve all grown accustomed to the Waterfall methodology, but today we are discussing using an agile approach, and how we’ve implemented agile principles into our Project Management Philosophy and moving beyond outdated Computer Systems Validation methodology and into Computer Software Assurance while decreasing cost and timelines.

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Episode 12: 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.

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Episode 11: 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.

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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.

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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.

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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

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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.

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Episode 6: Ensuring Right-Sized IRT Training for Any Sized Trial

Training is needed in any industry, but is required in the pharmaceutical world. Many companies overlook training on an IRT system, and then feel the repercussions when it comes to regulatory reviews. In this latest episode industry experts discuss different approaches, proven methods, and ways to cut down on cost, time, and effort in order to have your staff trained and ready for your next clinical trial, regardless of size or therapeutic area.

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Episode 5: Data Integrations: Everything you ever wanted to know but were afraid to ask

Data drives the clinical trial world. In this episode, we discuss the modes and methods on obtaining your data from an IRT, what is important, and common pitfalls you may encounter. Joining me for this robust discussion are industry experts who have extensive experience planning, developing, and implementing all types of data transfers, integrations, and exchanges.

  

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Episode 4: Lost in Translation: The Importance of Foreign Language Accuracy in a Clinical Trial

As Clinical Trials take a global approach, one major consideration people often overlook is foreign languages. We reached out to experts in this field to discuss the business of translations, what to look for, and any other considerations that need to be accounted for. An incorrect translation has the potential to ruin a clinical trial. We want to help you avoid any potential roadblocks with this informative episode about languages.

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Episode 3: IRT Design Considerations

Clinical Trials are becoming more and more complex. We’ve pulled our experts together to discuss those complexities and how you can navigate to ensure a successful study. In this episode we further discuss options around customizations and flexibility that must be built into your Interactive Response Technology (IRT) system. We are joined by a few experts who have designed hundreds of IRT systems and lend their expertise to a discussion to help you determine some best practices for your next system.

Suggested resources on this topic:

Latest IRT Systems Accelerate Trial Progress And Support Patient Safety

Are you Equipped with an Inspection-Ready IRT?

Interactive Response Technology: An Untapped Source Of Historical And Real-Time Data For Risk-Based Monitoring

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Episode 2: Completeness and Accuracy of the Clinical Supply Journey

On a Clinical Trial you need to know more than the kit assigned to a patient. The expectation is that your drug is accountable, reconciled and tracked at all times. Our panel of experts discuss the journey drug takes on a clinical trial, from depots to patients and everywhere in between and why you need to keep track of it. We are joined by former site coordinators and monitors turned drug management experts to help us follow drug through its journey. Our experts share excellent information about ensuring you can maintain compliance and manage your inventory accordingly.

Suggested resources on this topic:

Accountability & Reconciliation Tracking (ART™)

Integrating The Digital and Physical Supply Chain: Optimal Performance, Reduced Risks, and Lower Costs

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Episode 1: Relationship Management

With the recent updates to the ICH E6 there is increased scrutiny on Sponsor Oversight. In this episode I have a conversation about what successful relationship management looks like, different approaches to making it work amongst varying sized companies. Our experts discuss their approach to partnering with clients, and ensuring compliance with the updated regulations. We discuss the strategies, processes and structures to ensuring a successful trial.

Suggested resources for this topic:

Maintaining Compliance with New IHC Monitoring Guidelines

Boehringer Ingelheim Relies on Almac Clinical Technologies for EDC/IRT Integration: Consultative Approach Guides Successful Implementation

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The Spotlight on IRT: Best Practices Trailer

Listen for a preview of Spotlight on IRT: Best Practices podcast. Episode 1 is coming soon!

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