Just what is General Data Protection Regulation (GDPR) and how will it impact clinical trials? This article explores one aspect of GDPR, specifically, the right to be forgotten, and how it is implemented for the collection and use of clinical trial subject data.
Clinical Data managers are responsible for defining how clinical study data will be collected, and managed, in relation to the intake and quality of the data throughout the trial. While this sounds simple enough, it has become an increasingly challenging task due to changes in technologies, processes, regulations, and the growing complexity and diversity of the data.
Digital transformation is sweeping the health sciences industry, enabling companies to accelerate the pace of innovation. At the fifth annual Oracle Industry Connect conference, held in April 2018 in New York, attendees from all over the globe had an unprecedented opportunity to learn from experts – and one another – about the latest innovations driving that transformation in key areas including clinical trials.
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.
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.
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...
Many investigator sites cite the payment and reimbursement process as one of the most challenging in conducting clinical research. Many sites often are not reimbursed in a timely manner, which can negatively impact the cash flow status of a site. Additionally, many research sites, outside academic research institutes, do not use a system for accounting. Rather they rely on spreadsheets or manual processes for reimbursements.
Today the trend in healthcare is to provide the patient with as much value as possible. Though value comes in many forms, an important one that is often given less priority than others is patient engagement. That is, enabling the patient to take a more active role in the treatment of his or her condition. One study by the UK’s Centre for Health Policy focusing on patient engagement sought to shift the clinical paradigm from determining “what is the matter?” to “what matters...