Posts Tagged ‘pharmacovigilance’

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, […]

Many questions and concerns have been floating around the Oracle Health Sciences customer community about Argus Safety’s future on-premises releases. That’s great news for customers who are running the system in-house and might want to upgrade. As a partner with deep expertise in Argus, as well as PV/safety services that include application support, cloud hosting, […]

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, […]

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 […]

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 […]

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, […]

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 […]

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 […]

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 […]

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 […]

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, […]

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 […]