Protocol updates and unforeseen changes to a clinical trial may be a fact-of-life. When a change control is required to a validated IRT system it can be a daunting task to ensure that all progresses smoothly. If your study team finds itself facing a protocol amendment one of the first things you should do is…
Articles
Key Criteria in Selecting a Medical Coding Solution
Medical Coding software is often one of the most overlooked clinical software technologies. Coders are often subjected to using simplistic Medical 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 something spun out of another product. This results in fragmented…
Interview: Lead ISO Auditor: Part I
As part of the eclipse commitment to quality, we submit to annual audits from a third-party auditing firm to review our deliverables and Quality documents each year. This is the first in a two-part series conducted by Kristie Lively, Vice President, Clinical Operations & Quality Compliance with a lead auditor from our selected firm –…
How to: IRT Shipment Cancellation Best Practices
This step-by-step guide will help you understand how to successfully cancel an order when using an Interactive Response Technology (IRT)system When canceling shipments for a study using an IRT system for drug management, make sure you know how IP orders are processed. IRT systems generally create drug requests under three conditions: upon initial site activation…
3 Key Components to Risk Based Monitoring
Risk Based Monitoring is about using the right people, clear processes and superior tools to run a better trial. Risk Based Monitoring (RBM) is an increasingly popular approach to site monitoring and clinical data management that allocates resources based on risk and need, as opposed to delegating resources equally, regardless of each site’s unique challenges.…
Think you know InForm™?: A closer look at the industry’s leading cloud-based EDC system
Electronic Data Capture (EDC) systems are increasingly crucial to successful trial execution—but one should ensure that you choose one that brings with it maximum advantages. Today, the majority of clinical trials use an InForm EDC solution, as its helps ensure the data is clean, improves efficiency and provides real-time access to vital data. This increased efficiency…
IVRS vs IRT. What’s the difference?
IVRS vs IRT. What’s the difference? When people talk about clinical technology, the abbreviations and acronyms can be overwhelming. Two terms in particular, frequently cause confusion. Both have similarities, yet are also different. Interactive Voice Response Systems (IVRS) imply the use of telephone only as the interface to the technology side of a clinical trial.…
Is Risk Based Monitoring the future of clinical trials?
When and why to opt for Risk Based Monitoring, an increasingly popular approach to clinical trial site management Site monitoring is one of the most costly factors of clinical trials. Traditionally, clinical trial teams have had to allocate equal resources to all study sites, regardless of risk. When adopting a Risk Based Monitoring approach, you…
5 reasons for conducting clinical trials on Rare Diseases
In the United States, a Rare Disease is usually defined as a disease or condition that affects less than 200,000 people. This is usually an estimate and may change over time. Here are the top 5 reasons for conducting clinical trials on Rare Diseases.
Changing the View of Patient Care
The way patients receive care and what patients expect from providers is changing at an unprecedented pace. Patients are generally more informed and educated about their role in seeking care, and what they can and should expect from healthcare providers. Recently, USA Today highlighted five major changes we will see in healthcare in the next…
