Spotlight on IRT: Best Practices

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.     

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an agile approach, and how we’ve implemented agile principles into our Project Management Philosophy and moving beyond outdated Computer Systems Validation methodology and into Computer Software Assurance while decreasing cost and timelines.   

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.   

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.   

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.     

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.     

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     

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.       

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.       

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.