Advarra Launches AI- and Data-Backed Study Design Solution to Improve Operational Efficiency in Clinical Trials

 Powered by Braid, Advarra's Recently Introduced Data and AI Engine, the New Solution Unlocks Insights
into Trial Design Feasibility by Leveraging the Industry's Largest and Richest Set of Digitized Protocol-
Related Documents and Operational Data

COLUMBIA, Md., Sept. 16, 2025 /PRNewswire/ -- Advarra, the market leader in regulatory reviews and a leading provider of clinical research technology, today announced the launch of its Study Design solution, which uses AI- and data-driven insights to help life sciences companies design protocols for greater operational efficiency in the real world.

Study Design solution evaluates a protocol's feasibility by comparing it to similar trials using Braid™, Advarra's newly launched data and AI engine. Braid is powered by a uniquely rich set of digitized protocol-related documents and operational data from over 30,000 historical studies conducted by 3,500 sponsors. Drawing on Advarra's institutional review board (IRB) and clinical trial systems, this dataset spans diverse trial types and therapeutic areas, provides granular detail on schedules of assessments, and tracks longitudinal study modifications, giving sponsors deeper insights than solutions based only on in-house or public datasets.  

"Too often, clinical trial protocols are developed without the benefit of robust comparative intelligence, leading to inefficient designs and operations," said Laura Russell, senior vice president, head of data and AI product development at Advarra. "By drawing on the industry's largest and richest operational dataset, Advarra's Study Design solution delivers deeper insights into the feasibility of a protocol's design. It helps sponsors better anticipate downstream operational challenges, make more informed decisions to simplify trial designs, and accelerate protocol development timelines."

Advarra's Study Design solution can be used to optimize a protocol prior to final submission or for retrospective analyses. The solution provides insights on design factors that drive operational feasibility, such as the impact of eligibility criteria, burdensomeness of the schedule of assessments on sites and participants, and reasons for amendments. Study teams receive custom benchmarking that allows for operational risk assessments through tailored data visualizations and consultations with Advarra's data and study design experts. Technical teams can work directly within Advarra's secure, self-service insights workspace to explore operational data for the purpose of powering internal analyses, models, and business intelligence tools.

"Early pilots have already demonstrated measurable impact," added Russell. "In one engagement, benchmarking a sponsor's protocol against comparable studies revealed twice as many exclusion criteria and 60 percent more site visits than industry benchmarks. With these insights, the sponsor saw a path to streamline future trial designs by removing unnecessary criteria, clustering procedures, and adopting hybrid visit models, ultimately reducing site burden and making participation easier for patients."

Study Design solution is the first in a series of offerings by Advarra that will be powered by Braid. Future applications will extend insights beyond protocol design to improve study startup, enhance collaboration, and better support sites. To learn more or to request a consultation, visit the Study Design solution page on Advarra's website.

About Advarra
Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials. Advarra is number one in research review services, a leader in site and sponsor technology, and is trusted by the top 50 global biopharma sponsors, top 20 CROs, and 50,000 site investigators worldwide. Advarra solutions improve collaboration, transparency, and compliance to optimize study design and operations. With unmatched trial operations data, and an ongoing investment in AI innovation, Advarra continues to reimagine what's possible in clinical research. For more information, visit advarra.com.

SOURCE Advarra