Registration is now OPEN for Pistoia Alliance Conference: Collaborative R&D in Action on April 20-21 & 23, 2021.
Click here to save your seat for this free conference.
Where Life Science
Collaborates
We are a global, not-for-profit members’ organization working to lower barriers to innovation in life science and healthcare R&D through pre-competitive collaboration.
Registration is now OPEN for Pistoia Alliance Conference: Collaborative R&D in Action on April 20-21 & 23, 2021.
Click here to save your seat for this free conference.
Our projects transform R&D innovation through pre-competitive collaboration. We bring together the key constituents to identify the root causes that lead to R&D inefficiencies. We develop best practices and technology pilots to overcome common obstacles.
The Pistoia Alliance Informed Consent blockchain project will demonstrate the value of blockchain technology in underpinning the clinical trial Informed Consent process.
Obtaining and revoking consent in clinical trials is a complex process involving multiple stakeholders, documents and transactions in which the creation and maintenance of a secure audit is imperative for regulatory purposes. Blockchain is an emerging technology which enables secure transactions between parties by creating an immutable record of these transactions and storing them as part of a decentralised system.
Demonstrate the value of blockchain technology in the Informed Consent process by creating an end-to-end audit trail in a secure and consistent manner, underpinning a higher level of trust between stakeholders participating in a clinical trial.
Get in touch
If you would like to get involved or have further questions or feedback email the project manager, Richard Norman.
Bringing the industry together to define quality in study design and reporting for digital medicine by establishing consistency in the evidentiary base used to support clinical applications of digital medicine tools.
To achieve broad adoption and positively impact health, digital medicine products require evidence to demonstrate that they are trustworthy. The quality and quantity of evidence required to deem a product fit-for-purpose are not agreed upon by industry, patient, or government stakeholders. Currently, there is no consensus on what constitutes “evidence” or what metrics should be used to distinguish high-quality evidence from low-quality evidence.
Defining quality in study design and reporting will drive the field of digital medicine towards maturity by establishing consistency in the evidentiary base used to support clinical applications of digital medicine tools. This will in turn allow trials to be run in a distributed fashion, collecting more critical data which will help produce better outcomes and more precision medicines.
The project will combine inputs from the key areas of digital medicine – patients, CROs, sponsors and technology companies to ensure that each stakeholders requirements are considered.
SEED will enable a FAIR aligned comprehensive semantic capture and translation of data across eLN providers at the point of entry. Output will be computer readable standard data, increasing capacity for provenance and attribute connection for insight and analysis
Through collaboration and alignment across the pharma industry, the SEED project will create a standardized computer readable FAIR aligned data foundation.
A working prototype solution will be created to enable data discoverability/insights inter and intra eLN system.