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Drug-Induced Live Injury – Causes, Identification and Risks

This afternoon at the DIA Pharmacovigilance and Risk Management Strategies Conference in Washington, D.C, we are digging down into one of the cruxes of surveillance in pharmacovigilance (PV); drug-induced live injury (DILI). Vicky and I attended a panel consisting of hepatic experts sharing information on the latest drug-related DILI and the best way to detect […]

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Opening Remarks from the DIA Pharmacovigilance Strategies Conference

Today marks the beginning of the DIA Pharmacovigilance and Risk Management Strategies Conference in Washington, D.C., and the aura around the event is incredible. Industry speakers, short courses, hot topics, networking, education, and round-table discussions. All dedicated to enhancing the foundation for strong strategic planning and practical decision-making in pharmacovigilance programs. The Perficient team is […]

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Improving Pharmacovigilance Surveillance With Real-Time Tools

New codes of practice and guidelines in the EU and US hold marketing authorization holders (MAH) to higher standards for the surveillance of adverse event (AE) and product quality complaint (PQC) data. While good pharmacovigilance (PV) and safety surveillance is a required practice, companies agree that having more and better insight into their data can […]

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Is Your Oracle Siebel CTMS Application Slow?

Is your Oracle Siebel CTMS Application slow? Siebel message broadcasting could be the reason! The Siebel message broadcasting feature is typically used by application system administrators to send important information to application end users about system downtime and system availability. In recent Open UI versions of Siebel, this notification appears at the top right corner […]

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Argus Safety, Oracle Clinical & RDC Release Notes [Jan. 2020]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, including: Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Generally speaking, we review release notes at the beginning of each month for the previous month. On occasion, there are no new releases and, therefore, nothing to review; however, […]

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What The Three Little Pigs Taught Me About Pharmacovigilance Analytics

The pain points and the reality of safety surveillance within a sound risk management program are daunting. The expanded pharmacovigilance analytics (PV) landscape, geography, product type, and most importantly, regulatory changes are important considerations. Like the plague, risk management and drug surveillance panic spread quickly. How to keep up and have a meaningful understanding of […]

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Getting Started with Robotic Process Automation in Life Sciences

Previously, I examined how robotic process automation (RPA) can improve document compliance. The final installment of this series explains how to get started with RPA. The opportunities to use robotic process automation are almost limitless. The examples presented in this guide are just a few areas in which RPA can be used in life sciences […]

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Cloud Resource Security – Shared Responsibility Model

In my previous post on Cloud Resources – Policy and Practice, I referenced the “shared security model” adopted by all cloud providers. In this post, we will dive deeper into the differences and consequences of sharing the responsibility for securing computing resources, applications, data, and networks. Whether your organization is extending into cloud-based resources or […]

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Artificial Intelligence: Success Criteria in Life Sciences

Previously, I dove into how artificial intelligence helps review, and provide statistical analysis to data. The final blog of this series outlines how to be successful with an artificial intelligence implementation. Setting initial expectations and not promising a magic bullet is a key factor in determining the success of an initiative that focuses on deploying […]

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Robotic Process Automation Improves Poor Document Compliance

Previously, I explained how robotic process automation can assist updating outdated contact details. This blog examines how robotic process automation (RPA) can improve document compliance. Keeping sites in compliance with their required documentation is an ongoing battle for every sponsor and CRO. Considering the volume of documentation involved in a clinical trial, it is no […]

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Argus Safety, Oracle Clinical & RDC Release Notes [Dec. 2019]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, including: Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Generally speaking, we review release notes at the beginning of each month for the previous month. On occasion, there are no new releases and, therefore, nothing to review; however, […]

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AI Helps Review Plans, Data and Robotic Process Automation

My last installment explained how artificial intelligence (AI) assists search, confidence scores, and data reviews. This blog dives into how artificial intelligence helps review plans, provide statistical analysis to data, and robotic process automation. Review Plans Prior to starting data review, each team has its own review plan. The data review team has a data […]

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Robotic Process Automation Can Update Outdated Contact Details

My last blog discussed enhancing slow recruitment with robotic process automation. This installment explains how robotic process automation (RPA) can assist updating outdated contact details. At first glance, having outdated contact information for sites might seem like a relatively minor issue. But when it results in delays related to required documents, monitoring visits, or clinical […]

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Value-Based Care Models as Alternatives to Fee for Service

Many major providers did not properly plan for the previous presidential election results. Aetna CEO, Mark Bertolini, according to an article published in the Hartford Courant, sent his team back to the drawing board to develop another plan due to the potential repeal of the Affordable Care Act by the Trump administration. Many Payers are reeling […]

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The Evolution of Care Management – Managing Patient Outcomes and Costs

How Payers and Providers are using Population Health Management to improve patient outcomes and manage costs. According to Markets & Markets, the largest market research firm worldwide: “The population health management market is projected to reach USD 42.54 Billion by 2021 from USD 13.85 Billion in 2016, at a CAGR of 25.2% in the next […]

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Agile Street Smarts Series: Agile Estimation Levels and Techniques

This blog is part of a series exploring Agile methodologies. Read the last post in the series here. This post will explore Agile estimation and the different estimation techniques. Estimation is more the “art” than the “science” of program management so polish the crystal ball and let’s get started. Agile estimation is fundamentally different from […]

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Robotic Process Automation Can Enhance Slow Subject Recruitment

My last blog dove into robotic process automation fixing mistakes in clinical data entry. This blog highlights enhancing slow recruitment with robotic process automation (RPA). Even the most promising clinical sites can have trouble recruiting enough eligible subjects. Pressure from upper management or the sponsor to meet recruitment targets causes stress and anxiety for study […]

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AI Helps Search, Confidence Scores, and Data Review

Previously, I analyzed clinical data review platforms. This blog explains how artificial intelligence assists search, confidence scores, and data reviews. Search Data managers and reviewers log in to clinical data review platforms (CDRP), and slice and dice the data they want in order to review for missing, wrong, or inaccurate data. If they can search […]

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Cloud Procurement Approval Management

Cloud Procurement offers a new interface defining approval workflow for Requisitions, Purchase Documents (Order, Blanket, Contract) and Supplier Management. Approval rules are managed in a user friendly interface that integrates back-end Business Process Management (BPM) while keeping a logical and complete setup in front of the user. While relatively simple to define rules in Approval […]

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Install, Configure, Deploy FileNet P8 using Ansible

Here is something I’m working on at Perficient to make installing/upgrading, configuring, and deploying IBM FileNet P8 more efficient. It even creates a Domain, and Object Store. All using Ansible. If your organization is looking to implement something like this in your environment, give Perficient a call. We’ll be happy to assist.    For […]

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