An Integrated Solution for the Retention of Electronic Study Data
We make investigator data storage easy!
About Us
The Concept
Clinical trial conduct has evolved and will forever be driven by digital forces – this is excellent for patients and for speed to develop new products.
It has and continues to present a challenge on how to handle this data.
Storage and access to electronic clinical trial is a challenge for Clinical Sites, Sponsors, Partners and Regulators.
Our concept is to have a 'one stop shop' for all clinical investigator data for post-trial/ post-submission storage, which can be restored into an authentic format when needed (e.g. during regulatory inspections or audit)
Why Now?
- Driven by increase in decentralised trials
- Pervasive shift to digital technology and electronic systems
- Increased use of Apps and wearables
- Accelerated by Covid
- Greater focus on patient centric trials
- Regulators responding with draft regulations – FDA and EMA
Currently Recruiting Partners
We have been approached by many companies and institutions for collaboration and are currently exploring partnerships with Sponsors and Investigators.
If you would like to be considered in our first cohort and help shape the product contact us now.