Life Sciences

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, […]

I recently recorded a video in which I discuss three cost-effective methods to track clinical supplies in Oracle’s clinical trial management system (CTMS): Out-of-the-box clinical supply management (no configuration) Clinical supply management with minimum-level effort configurations Enhanced clinical supply management with medium-level effort configurations This short video shows you just several of the different options […]

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 […]

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 […]

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, […]

I recently shared a project in which we helped a pharmaceutical company build studies in Oracle InForm. Today, I want to share a project that has to do with the length of time it took for a major pharmaceutical company to run Oracle InForm reports, which caused significant problems, including delays in being able to […]

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 […]

The beauty of having a versatile team of clinical data management experts is that they understand the life sciences industry and how companies operate. Through client projects and having worked at pharma companies in previous roles, they know the many unique challenges and needs of pharmaceutical and medical device companies. Equally important, they’re also technologists. […]

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 […]

Secure Software Development Understanding security policies and how they apply to development practices is key to delivery of secure software.  Unfortunately, most development teams do not have a clear understanding of security implementation.  This may be due to several factors, but a common theme is that security professionals speak a different ‘language’ from developers (i.e. […]

My last bog talked about mitigating data overload with proactive pharmacovigilance (PV). The next blog in this series analyzes the history of PV, AEs and clinical therapeutics. As early as the 1980s, it was recognized that prostaglandins were important in renal function, especially in hypertensive patients. Prostaglandins preserve and maintain renal blood flow and thus […]