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Operations

Is Risk-Based Monitoring Just A Fad?

  While some of you might be hoping that RBM is just a trendy idea that we’ll soon forget, I have to say that when regulatory agencies take the time to draft and produce guidance documents on the topic… 

How to Load Oracle Data into SparkR Dataframe

In the Spark 1.4 and onward, it supplied various ways to enable user to load the external data source such as RDBMS, JSON, Parquet, and Hive file into SparkR. Ok, when we talk about SparkR, we would have to know something about R. Local data frame is a popular concept and data structure in R […]

#HIMSS16 Hot Topic: Cost Management- Correlate Cost & Quality

When we take a look at the hot topics for #HIMSS16 it is no surprise that cost management is on the list. Healthcare organizations are continuing to understand the value of enterprise-wide transparency in order to lower the cost of care and improve the quality of care for the populations they serve. For that to […]

Trending: Using EHR Data To Determine Site/Study Feasibility

  According to an article in Clinical Leader that featured Bayer Healthcare’s VP Global Strategy & Development Advisor, by evaluating certain criteria against patient populations, electronic health record (EHR) systems can help sponsors determine trial feasibility and shape better study protocols. This can reduce the number of amendments, which can cost anywhere from $300,000 to […]

#HIMSS16 Hot Topic: Enterprise Performance Management

Anticipating the hot topics at HIMSS can be a mind boggling experience. However, I can bet topics that revolve around the Triple Aim will be at the top of the list. Today, I sat down with Terie McClintock, MBA, Director, Healthcare Solutions, Perficient to talk about enterprise performance management and its importance in an ever-evolving […]

Is Risk-Based Monitoring Compliant?

  When we think of compliance, we think of consistency. Compliance depends on following the same processes and procedures over and over, across the board. After all, that’s why we have all of those SOPs, right? When we’re used to conceptualizing compliance this way, the notion of risk-based monitoring can certainly lead to cognitive dissonance. […]

Ya Man! Fighting Zika With Reggae Music

  It’s often said that “music heals.” While it may not cure disease, some nations are turning to music in an attempt to prevent it. Jamaica’s Ministry of Health produced a reggae music video that’s about Zika, a virus that is spread through mosquito bites. According to the Center for Disease Control (CDC), Zika is […]

Should Pharma Share Clinical Trial Data?

  Let me preface: this is just me playing devil’s advocate. To be fair. To give a different perspective. There is an exorbitant amount of conversation going on about the sharing and publication of all clinical trial data, good or bad. The reason? To help others out. To advance science. To save lives. 

Leading Organizational Transformations: A Digital Perspective

McKinsey has a long but great article on Leading Organizational Transformations. It’s very focused on the generic need of transformation rather than my more specific focus on digital transformation but the description of the problem and recommendations on approach make sense in both use cases. The problem Let’s face it, most attempts at transformation of […]

New Report: Industry Still Manages Commercial Content Manually

  Efficiency and compliance are two critical components in highly-regulated industries, especially when it comes to developing drugs and medical devices. Unfortunately, though, these are two areas in which many life sciences companies struggle and could significantly improve through IT solutions. 

Using ODI Multiple Export Utility

This post explains the process of using ODI Export Multiple Objects utility to export selected multiple ODI objects and importing them individually. ODI introduced a new feature ‘Smart Export’ from version 11.1.16, This feature automates the process of exporting/importing all objects related to your change, As BIAPPS OOTB ODI repository contains thousands of objects smart […]

Does Risk-Based Monitoring Cheat In Source Data Verification?

  Because risk-based monitoring does not involve 100% source data verification (SDV), unlike traditional monitoring, it’s understandable that RBM could seem sort of like “cheating.” But, research has shown that 100% SDV does not consistently result in higher quality data. In other words, the cost of 100% SDV outweighs the potential benefits. 

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