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an agile approach, and how we’ve implemented agile principles into our Project Management Philosophy and moving beyond outdated Computer Systems Validation methodology and into Computer Software Assurance while decreasing cost and timelines.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