Articles

Best Security Practices for Protecting Patient Health Information

Any organization that is in the business of working with patient health related information should make information security one of their highest priorities.  Important regulations such as HITECH (passed by Congress in 2009 which implemented stricter penalties for HIPAA violations), the HIPAA Security Rule (addresses the protection of patient information in electronic format), and the…

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Easing the Anxiety for Go-live with Interactive Response Technologies

Study Go-live for interactive response technologies (IRT), (IRTor IxRS) is always a rigorous process.That being said, there are always ways to compensate for last minute changes and setbacks.  The following simple techniques can ease any go-live concerns: Go-live checklist: Use a go-live checklist to ensure your interactive response technologies vendor has one to utilize for your…

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Interview: Lead ISO Auditor: Part II

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 part two of the series conducted by Kristie Lively, Vice President, Clinical Operations & Quality Compliance with a lead auditor from our selected firm – Kris…

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Considerations when Study Changes impact the IRT system

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…

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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…

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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 –…

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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…

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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.…

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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.…

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