Background of Diabetic Market in the US According to a 2020 Center for Disease Control (“CDC”), the United States has approximately 34 million people with diabetes. Of these, the Juvenile Diabetes Research Foundation (JDRF) estimates that 7% are Type 1, meaning their body produces no insulin, and cannot survive without does of insulin. Of the […]
FDA Approves Marketing of AI/ML Device To Find Colon Cancer
The Impact of Colon Cancer According to the National Institutes of Health (NIH), colon cancer is the third-leading type of cancer death in the United States. Cancer in the colon usually starts from polyps or other precancerous growths in the rectum or the colon (large intestine). As part of a colorectal cancer screening and surveillance […]
The Importance of the Unified Platform Approach for Clinical Development
Attending the Oracle Health Sciences Connect 2021 conference session “The Importance of the Unified Platform Approach” triggered me to think about the overall clinical trial life cycle. The COVID-19 pandemic has set an expectation for companies to develop vaccines and other health solutions for their customers more quickly. This is only possible by having an […]
Is the Clinical Development Platform Approach Right for You?
Life sciences organizations typically manage their IT infrastructure and applications in silos. They implement disparate applications and manage the content and process within those applications separately. They then deploy integrations between those applications to streamline processes and share content and data with different business areas. Much of this work, including the development of integration tools […]
Argus Safety, Oracle Clinical & RDC Release Notes [April 2021]
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, […]
Regulatory Updates for Safety: Oracle Health Sciences Connect 2021 Session Recap
During a session at this year’s Oracle Health Sciences Connect conference, Oracle presented recent and upcoming regulatory updates from regulatory agencies around the world for safety. Due to the pandemic and new COVID vaccines, the regulatory update that piqued my interest most was related to the Postmarketing Safety Reporting (PMSR) requirements for Combination Products. The […]
Overview of FDA’s AI/ML-Based Software as a Medical Device Action Plan
In a landmark effort to both guide and spur artificial intelligence (AI) and machine learning (ML) development in the medical field, the US Food and Drug Administration (FDA) has released an Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. Background The plan was created by the FDA’s Digital Health Center of […]
Customer Experiences With Clinical One
During Oracle Health Sciences Connect 2021 this week, some Oracle clients have been sharing why they decided that after 20 or so years using InForm, it was time to transition to Clinical One. The technical drivers for making this move include moving off antiquated architecture to a SaaS model with automated system upgrades. The business […]
Oracle Health Sciences Connect 2021 Starts Today
I am looking forward to hearing from Oracle over the next couple of days at Oracle Health Sciences Connect about the roadmap for Clinical One and Safety One, in addition to customer experiences so far. These innovations could influence how clinical trials are run in the future and enable steps towards the elusive single source […]
Healthcare Success Story with Boomi & Moderna
For the past year, major health care providers and research centers have been focused on one goal – minimizing the negative effects of the pandemic. One of these providers, Moderna, has been a front runner in the research, development, and dissemination of a successful COVID-19 vaccine. Due to their increased efforts and high demands, they […]
Lift Off to the Oracle SCM Cloud! – Why Move to Cloud for SCM Enablement?
One of the biggest challenges companies face with their SCM applications footprint is moving part or all of it to a cloud-based SaaS/PaaS platform. This decision is sometimes complicated by the fact that on-premise license renewals, de-support notices for earlier versions of EBS, ‘true ups’ for user license fees (especially when there has been significant […]
Argus Safety, Oracle Clinical & RDC Release Notes [Mar. 2021]
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, […]