Articles

4 Steps to a Quality by Design Approach to RBM

Risk Based Monitoring (RBM) is a proactive, strategic approach to site monitoring and clinical data management that allocates resources based on need. It goes hand in hand with Quality by Design (QbD), a concept that has been embraced by nearly every industry to help improve processes and create quality products. It’s based on the idea…

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Why IRT integrations are important to the success of your next clinical trial

An IRT system with a robust drug management and data integration function is a crucial component to any clinical trial. Here are some of the benefits of common IRT integrations. When Interactive Response Technology (IRT) integrates with other software systems, you have the ability to seamlessly access important data from other sources and better leverage…

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Can application testing be fun, yet still provide maximum quality?

As we all know, testing is an integral part of any application development process. It should not be relegated to a specific stage of the development cycle, and most definitely should not be the last thing on a To-Do list, just before handing over the application to your client. In a way, testing defines a…

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Manual Drug Assignment in IRT

IRT systems can make your trials run smooth and efficiently, but unexpected variants can occur. Proper contingency planning can make unexpected eventualities a little easier to deal with. There could be a time in an IRT trial when the system cannot dispense medication for one reason or another. This may be due to a system…

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The Importance of Language Translation in Clinical Trials

The past decade has witnessed a rapid expansion of clinical trial market into diverse cultures and languages. This development has increased awareness of the complexity of running global clinical trials and resulting language challenges. The issue of language is particularly critical as accuracy of research and drug development process is key to achieving successful results.…

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IRT Label Types

IRT drug management is a powerful tool for drug supply teams to leverage for trial supply activities. One of the tools IRT brings to the task of supply management is the label type or label group setting. At times this setting can be confusing because IRT nomenclature can sometimes overlap with clinical supply terminology that…

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Implementing Drug Pooling through Technology

In certain situations, sponsors may need to consider drug supply pooling for their larger program level drug studies. This can allow them to consolidate supply lines and cut costs. So what exactly is drug pooling and what does it mean for IRT? Drug pooling is the ability to provision drug supplies between a central depot…

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Life after dsNavigator, moving to a new coding system

Coding software is often one of the most overlooked clinical technologies.  Coders are often subjected to using simplistic coding tools that were built in house many years ago. Coding tools built into a piece of OTS (off the shelf) software designed for another purpose, or sometimes your favorite product retires before you.  This can result…

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Handling Ancillary Supplies

Some clinical trials will require ancillary supplies such as sharps containers, blinding bags, or IV tubing in addition to investigational study drug as part of the protocol. Managing ancillary supplies and study drug using an IRT system requires special consideration. First consider if the ancillary supplies need to be serialized or if they can be…

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Maintaining the Blind

In clinical trials maintaining the study blind is critical. A compromise in blinding can cost a study team subjects, drug kits or in the most extreme circumstances, the study itself. Careful consideration should be given when dealing with any information that could be potentially unblinding. Types of things in a trial that could be potentially…

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