Technology Standards for Life Sciences

Align Clinical CRO’s technology standards are based on an agenda set by its leadership and aligned with the mission to make it easier for life sciences companies to work with CROs. As a foundation for improved collaboration, the group has established the development of a data exchange standard for operational metrics and data as its initial focus area.

These technology standards will be defined and codified by working groups, nominated by members and comprised of cross functional domain experts, representing diverse functions from clinical operations to information technology.

The Operational Data Exchange Standard

For every clinical trial run by a CRO for the industry, a set of operational data is defined that must be provided to the sponsor company. This set of operational data includes key metrics, milestones, and information that allows the sponsor to provide oversight, drive decisions and help the overall success of the trial.

The Operational Data Exchange standard will define the data and structure that technology companies can implement to consistently and easily exchange data between CROs and Sponsors in clinical trials. By doing so, clinical trials will be more cost efficient and more rapid to start up. The standard will include

Data Definitions — Leveraging other industry standards, the standard will include the data domain and data element definitions that need to be exchanged to support the oversight and management of the clinical trial.

Data Model — A standard model for the structure for the data will be defined allowing for technology companies to extract, process, and upload the data consistently into other clinical trial execution technologies.

The Operational Data Exchange Standard is expected to be published in mid-2018.