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an agile approach, and how we’ve implemented agile principles into our Project Management Philosophy and moving beyond outdated Computer Systems Validation methodology and into Computer Software Assurance while decreasing cost and timelines.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

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.    ..read more

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.    ..read more

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.      ..read more

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.      ..read more

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 Supp ..read more

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 ..read more

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 Clini ..read more

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

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.      ..read more