Life Sciences

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 […]

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, […]

In uncertain times like these its essential that we consider the disruption that is happening and take a nimble approach to help Organizations including my own by driving analytics and insights across the various Lines of Business. How can we take all the Public data that is available from John Hopkins, CDC, WHO and various […]

Surveillance of pharmacovigilance (PV) and product quality-complaint (PQC) data is not a new activity. For years we have known that adverse events temporal to drugs occur. Moreover, they are consistently underreported, impacting analysis of the data in unknown ways. Nearly every regulatory authority across the world has guidance and requirements in place for marketing authorization […]

With the shift to working from home, changing daily priorities, and resources during the COVD-19 pandemic, regulators have or are making transitions to ease the stress without losing valuable data that may contribute to the treatment of COVID-19 or interrupting clinical trials. The pace at which the information on COVID-19 itself appears is so fast; […]

There is no question that the pandemic COVID-19 has transformed life as we know it today. We are now operating in a different pharmacovigilance (PV) paradigm, adapting as we move daily. While patient safety remains the first priority, AEs will continue to come in for processing, and daily PV activities will continue. New therapeutic information […]

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, […]

My colleague, Christoph Brieden, recently presented on Perficient’s WHODrug Koda Interface at a webinar hosted by the Uppsala Monitoring Centre (UMC), which was attended by over 200 people. If you didn’t see the webinar and have a UMC login you can access a recording here. Although still at the prototype stage, we are keen to […]

Each year in March (and September), we eagerly await the new releases of the MedDRA dictionary, hoping that any suggestions we have provided during the year were accepted. We also know that a significant dictionary change can be a bit much during a busy time. MedDRA 23.0 will be released on March 1, 2020. In […]