This year’s Summit for Clinical Ops Executives (SCOPE) focused on innovation, patient centricity, real world data/real world evidence, wearable devices/mHealth, Blockchain, and AI/machine learning some of the most pressing topics impacting clinical development.
Bitcoin, cryptocurrency and worldwide payment system, is beginning to be cited in use cases beyond those just for currency. Blockchain, Bitcoin’s underlying technology, has real potential to support clinical research by preventing fraud in scientific literature and regulatory submissions.
As of January 2018, the Clinical Data Interchange Standards Consortium (CDISC) will provide its Platinum members with access to its Shared Health and Research Electronic library (SHARE), a set of technologies the CDISC uses to develop and manage industry clinical data standards.
Maintaining paper binders for clinical trial regulatory information is time consuming, requires on site updates, and lacks the flexibility for easy Sponsor access. Imagine electronic templates for this information, capable of being sent to an eTMF system automatically. This could significantly decrease the time it takes to get sites approved for study starts
Though not a new subject, eSource is still new to many investigator sites. Site teams have strong opinions about eSource, are still struggling to understand what it is, and wondering if it requires investment. Many teams prefer to select and implement their own eSource system and favor providing input on eSource requirements to application providers.
In anticipation of our upcoming Oracle Industry Connect event in New York City this spring, we are presenting Part 1 in a series of blog posts on life science innovation in the Empire State. In the coming months, we’ll explore how advances in New York’s clinical pharma and biotechnology communities are driving bioscience forward and helping to save more lives.
Next week, the Galien Foundation hosts the Prix Galien awards at The American Museum of Natural History in Manhattan. The gala event -- including the ceremony, cocktail party, and dinner -- recognizes outstanding achievements in pharmaceuticals, biotechnology, and medical technology that improve the human condition. The award is considered the equivalent of the Nobel Prize in life sciences research. Ever wonder how Prix Galien got its name? The award honors Claudius...
A data model is quite simply a 'description of the structure' of stored data. For example, a clinical trial in Oracle Health Sciences InForm is described by an InForm Clinical Trial Data Model. Data models are created by applications to store data and accessed by end users to manipulate data. Data models are important because they help end users to access data that is easily understandable, meaningful, and useable. For example, an Oracle Health Sciences InForm Clinical...