To lower costs,shorten cycle times, and get life-saving medicines to patients sooner, the technology supporting clinical trials needs to be reimagined. Today, the power and efficiency of a cloud-based service environment offers the best hope to achieve faster, less expensive, more scalable trials.
An FDA representative recently explained that over 15,000 clinical trials are currently active around the world, with another 45,000 trials actively recruiting. This post shares how these statistics directly influence our view of clinical data today, and the technological direction needed to move toward the future.
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.
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.