Posts Tagged ‘pharmacovigilance’

Pharmacovigilance Innovation

[Watch] Using AI & Automation to Enhance Adverse Event Case Processing

Recently, Christine Livingston, Chief Strategist, Artificial Intelligence, Kari Blaho-Owens, Ph.D. Director, Safety and Pharmacovigilance, and Prabha Ranganathan, Director, Clinical Data Warehousing and Analytics, hosted a webinar with Bio-IT World that discussed how to leverage AI and automation to improve case processing. The implementation of such cutting-edge technology results in fewer manual processes, streamlines workflows, and increases consistency. It has the potential to transform your […]

Pharmacovigilance

[Watch] Transforming Pharmacovigilance Workflows with AI & Automation

Recently, Kari Blaho-Owens, Ph.D. Director, Safety and Pharmacovigilance, Prabha Ranganathan Director, Clinical Data Warehousing and Analytics, and Christine Livingston, Chief Strategist, Artificial Intelligence, presented a webinar on integrating AI and automation to transform and optimize an end-to-end pharmacovigilance (PV) system.  The implementation of such advanced technology improves data quality, consistency, compliance, and operational efficiency. The ROI can be significant.   You can find the one-hour webinar below, in which you […]

Capsule Package Production Line

Argus Safety, Oracle Clinical & RDC Release Notes [Sept. 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, […]

Young Pharmacist With A Tablet In Drug Store

Painless PADERs From Argus Safety Without Wonky Counts

Periodic Adverse Drug Experience Report (PADER) is a part of post-marketing cumulative safety reports that need to be submitted to the United States Food and Drug Administration (US FDA). It provides a brief summary of changing post-approval AE profiles and safety information of an approved drug along with the benefit-risk profile evaluation. The Oracle Argus […]

Healthcare Data

Avoiding Nuisances of Special Characters in Argus Safety

Special characters are useful and sometimes necessary for accurate interpretation of the content specifically for medical terms in PV cases. However, not all special characters are welcome in Argus Safety. If used, they have their own nuisances. Below are a few examples of irritating outcomes when special characters are introduced and the best practices to […]

Pharmacovigilance

The Future of Pharmacovigilance

Previously, I discussed how pharmacovigilance can work, when implemented correctly. In the final installment of this blog series, I look at the future of pharmacovigilance. How can you close the knowledge gap and move pharmacovigilance from a state of reactive to proactive? While the presented earlier is merely an example, it is based on real […]

Pharmacovigilance

Why Proactive Pharmacovigilance Can Work

My last two blogs compared a hypothetical example of reactive and proactive pharmacovigilance (PV). My next installment in this series outlines how PV can work. Rather than reacting to the data, in the second hypothetical scenario, Company A pivoted with ready-planned interventional pharmacovigilance practices at the level of the intake system and took a patient-centric […]

Pharmacovigilance

Perficient Wins Award for Its Pharmacovigilance Intelligence Solution

We are very excited to receive recognition for PV Hawk. Not only is it an honor, but it shows the value and flexibility of Perficient’s enthusiasm for bringing common sense to complex problems and the success of our cross-functional teams that contributed to getting this solution out. For many years, I, along with many others, […]

Pharmacovigilance

Proactive Pharmacovigilance: Another Real-World Example

My previous blog provided a hypothetical example of reactive pharmacovigilance. This blog will examine the opposite, proactive pharmacovigilance and the success it can bring. Company A launches a first-in-class drug/device combo biologic for the treatment of psoriatic arthritis. The drug has a novel mechanism of action. In clinical trials, ACR response was 26 weeks. The […]

Pharmacovigilance

Reactive Pharmacovigilance: A Real-World Example

Previously, I examined the best ways to overcome challenges with a new pharmacovigilance system. I now want to provide a hypothetical example of reactive pharmacovigilance. Company A launches a first-in-class drug/device combo biologic for the treatment of psoriatic arthritis. The drug has a novel mechanism of action. In clinical trials, the American College of Rheumatology […]

Scientists Discussing And Using Computer Software

Overcoming Challenges with a Pharmacovigilance System

My last blog outlined the potential for increased return on investments when pharmacovigilance is implemented. The next blog in this series discusses the best ways to overcome any challenges with new systems. Looking at a pharmacovigilance system holistically, there are interconnected, interdependent parts. Understanding how those individual parts function independently, as well as their impact […]

Pharmacovigilance

Pharmacovigilance: The Return on Investment

Previously, I analyzed the history of pharmacovigilance (PV), AEs and clinical therapeutics. This post examines the potential for increased return on investments when pharmacovigilance is implemented. All AE data holds value; how that value is determined takes an astute scientific approach to surveillance. In 2001, the medical literature began to include the results of a […]

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