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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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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 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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Argus Safety, Oracle Clinical & RDC Release Notes [Nov. 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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Robotic Process Automation Fixes Mistakes in Clinical Data Entry

Previously, I discussed life science subject screening and how robotic process automation can assist. This next installment of the series dives into robotic process automation (RPA) fixing mistakes in clinical data entry. Dirty clinical data is one of the most costly aspects of clinical trials. Not only does the review and clean-up slow down time […]

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Machine Instruction 3.0: Express Your Desire

The evolution of expressing our machine instruction. Let’s get there together. Machine Instruction 1.0 In the past, we taught our computers what to do by expressing our desires with exact instruction. Classic computer programming that listed step by step instructions. We taught our machines how to behave. Arguably, even legacy artificial intelligence worked this way. Of course, this way of directing […]

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Clinical Data Review Platforms in Life Sciences (CDRP)

My last blog discussed how AI assists to create human-computer systems. This next blog in the series analyzes clinical data review platforms. While machine learning (ML) and natural language processing (NLP) functionalities are not currently available in today’s clinical data review platforms (CDRP’s), we know they offer tremendous benefits to the clinical data review and […]

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Subject Screening with Robotic Process Automation: Life Sciences

My last blog analyzed site monitoring, and how robotic process automation can enhance it. My next blog discusses life science subject screening and how robotic process automation (RPA) can assist. Even when sites are able to recruit a large pool of potential subjects, sponsors and CROs see far too many subjects who fail to pass […]

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Developing a Strategic Vision in Life Sciences

Previously I discussed how life sciences companies can establish better relationships with patients. This blog analyses developing a strategic plan and how to get started. When it comes to managing these relationships, the bottom line is that there are some dramatic shifts taking place in healthcare, and life sciences companies need to understand, harness, and […]

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AI Creates a Human-Computer System in Life Sciences

Previously, I discussed artificial intelligence (AI) enhancing clinical data review processes. This blog discusses how AI assists to create a human-computer system. Humans and machines each have their own strengths. On the one hand, machines are good at processing and analyzing large volumes of data with high speed and accuracy. On the other hand, humans […]

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