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Release Notes: Oracle/Perficient’s Clinical Apps [August 2017]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Perficient Systems ASCEND (Siebel CTMS) Generally speaking, we review release […]

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Top 5 Pharma & Medical Device Blog Posts From July 2017

Now that August is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in July – they’re ranked in order of popularity, with number one being the most viewed piece. All You Need To Know […]

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FDA Guidance On 21 CFR Part 11 And Mobile Tech In Clinical Trials

In June 2017, the United States Food and Drug Administration (FDA) issued a new draft guidance document for public comment: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers. You have until August 21, 2017, to share your thoughts and ideas about its content. The […]

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How To Use SmartScripts For Trip Reports In Oracle Siebel CTMS

Starting in Siebel IP2013, a little known enhancement was introduced in Oracle’s clinical trial management system (CTMS): the ability to incorporate Siebel SmartScripts directly into trip reports. What are SmartScripts? According to Oracle’s official documentation, “Siebel SmartScript allows business analysts, call center managers, and Siebel developers to create scripts to define the application workflow for interactive customer communications. […]

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What Pharmacovigilance Means And Why It Matters

Pharmacovigilance, or the practice of monitoring the effects of medicines after they have been released for commercial use, was expanded in 2002 by the World Health Organization (WHO) to include signal detection as a way of improving patient care and improving the overall health and safety of the general public. Today, pharmacovigilance activities should also […]

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How To Make Clinical Subject Recruitment Easier On Clinical Sites

Imagine with me: While surfing the web on his mobile phone, a young man receives an offer to apply to participate in a clinical trial. He thinks, “Why not?”, creates a user ID and password, and then follows a series of interactive prompts to build out his profile. While there are no current trials that […]

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All You Need To Know About Oracle Argus Safety 8.1 In 30 Minutes

Hi everyone, it’s Indy here. For those of you who may not recognize my name, I’ve been helping lead our Argus Safety installations for the past few years. I wanted to drop a quick note to personally invite you to the webinar I’ll be presenting next week. It’ll be relatively short, by design, but it […]

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Practical Ways To Keep Investigators Happy, Productive, And Loyal

This Thursday, July 13 @ 9 a.m. central time, my colleague (and one of my favorite people on the planet!), Param Singh, is delivering a 30-minute webinar on a really hot topic: clinical investigator retention. Trust me – this topic is worth 30 minutes of your time! What’s especially neat about this particular webinar is […]

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Release Notes: Oracle/Perficient’s Clinical Apps [July 2017]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Perficient Systems ASCEND (Siebel CTMS) Generally speaking, we review release […]

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Top 5 Pharma & Medical Device Blog Posts From June 2017

Now that July is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in June – they’re ranked in order of popularity, with number one being the most viewed piece. What Exactly Is An “Adverse […]

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How To Find Oracle Siebel CTMS Patchset Release 16.14

A couple of months ago, I wrote a blog post on how to find and install the latest patchset release for Siebel IP2016. While we’re in the middle of 2017 and still waiting for IP2017 to be released, Oracle managed to sneak in another patch release for IP2016. Below are a couple of screenshots that […]

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The Role Of Signal Detection In Drug Safety

Due to the seriousness of adverse drug reactions, life sciences organizations perform something called “signal detection,” which is the process of evaluating potential safety signals. This entails looking at previously known associations between a drug and an adverse event, and looking at previously known drug-related issues that may be either improving or worsening. Not only […]

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Alleviate Payment Pains For Clinical Sites And Investigators

Imagine with me: An investigator running a site in one of your studies logs in to see an overview of his payment history. Something seems off, so he begins to review each payment in detail, and comes across what he believes to be the source of the problem – the withholding for his first payment […]

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Consider This When Migrating To Argus Safety

When I’m approached by clients to discuss safety projects, it is generally about implementing Oracle’s Argus Safety, upgrading the system, or discussing their ability to comply with regulatory requirements. Recently, I was asked about migrating from a legacy drug safety database to Argus. We discussed the methods available, such as leveraging an Oracle dump, a […]

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What Exactly Is An “Adverse Drug Reaction?”

While there are many ways to define “adverse drug reaction,” let’s use one that is fairly simply to digest: an unintended, harmful response that is suspected to be caused by a medicinal product being taken under normal circumstances. According to some sources, adverse drug reactions are the sixth-leading cause of death in the United States, […]

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Release Notes: Oracle/Perficient’s Clinical Apps [June 2017]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Perficient Systems ASCEND (Siebel CTMS) Generally speaking, we review release […]

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Top 5 Life Sciences Blog Posts From May 2017

Now that June is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in May – they’re ranked in order of popularity, with number one being the most viewed piece. How To Import Data Into Siebel […]

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How To Disable List Applet Exports In Siebel In Just 3 Steps

As you might know, by default, you can export data from any Siebel list applet. Here is where you invoke the export: Recently, I had a client who wished to disable the ability to export data from Siebel, except for in one particular view. I’ve never seen this documented anywhere before, so I thought I […]

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Using Oracle DMW To Solve Clinical Data Review Challenges

In part one of this two-part blog series, we outlined a number of challenges that organizations face with clinical data reviews. In today’s post, part two of the series, we’ll take a look at how Oracle Health Sciences Data Management Workbench (DMW) can be used to tackle those challenges. DATA MANAGEMENT WORKBENCH (DMW) OVERVIEW When […]

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