Study Design

Advarra's Study Design solution is a clinical trial protocol optimization platform built for sponsors who need deeper, data-driven feasibility insights to improve operational efficiency. Powered by Braid — Advarra's proprietary data and AI engine — the solution draws on the industry's richest set of digitized protocol-related documents and operational data, going far beyond what in-house or public datasets alone can provide.

By surfacing intelligence on the design factors that drive operational feasibility, Study Design enables clinical teams to anticipate downstream challenges, simplify trial protocols, reduce site and patient burden, and accelerate protocol development timelines. It is purpose-built for sponsors, study teams, and technical teams seeking to ground protocol decisions in unmatched comparative intelligence.

Core Capabilities

• Unmatched data foundation: Leverages the industry's largest trial operations dataset, drawn from over 30,000 studies spanning multiple therapeutic areas, phases, and trial types, and encompassing over 170,000 protocol-related documents from more than 3,500 sponsors.
• Smarter visit design: Delivers granular insights into schedules of assessments to help optimize visit structures and reduce burden on both sites and participants.
• Clarity on study modifications: Provides visibility into longitudinal study modifications, revealing the key drivers behind protocol amendments so teams can proactively address them.
• Eligibility criteria analysis: Surfaces insights on how eligibility criteria impact operational feasibility, enabling sponsors to make informed simplification decisions.
• Protocol amendment intelligence: Identifies reasons for amendments to help teams reduce costly and time-consuming mid-study changes.

Flexible Consumption Models

• App (conversational AI): An on-demand, interactive application that allows clinical teams to ask open questions and explore trial operations data in real time, supporting rapid iteration of critical design decisions across stakeholders.
• Workspace: A secure insights environment where technical teams can work directly with operational data to power internal analyses, models, and business intelligence tools.
• Service: A managed offering in which study teams receive custom benchmarking, tailored data visualizations, operational risk assessments, and direct consultations with Advarra's data and study design experts.

Key Benefits for Clinical Trial Operations

• Process improvement: Accelerates the study design process by enabling fewer and smoother protocol iterations.
• Simpler designs: Minimizes operational complexity to help accelerate overall trial timelines.
• Competitive edge: Grounds protocol design decisions in unmatched operational intelligence, providing sponsors with a strategic advantage over teams relying on limited datasets.

Powered by Braid™ — Advarra's Data and AI Engine

• Braid aggregates a uniquely comprehensive set of operational data sourced from Advarra's institutional review board (IRB) and clinical trial systems.
• The engine transforms unstructured data — including digitized protocols and operational records — into actionable intelligence.
• Braid enables smarter trial design, faster decision-making, and streamlined execution across the full clinical trial lifecycle.
• Data coverage spans over 170,000 protocol-related documents and operations data from 30,000 studies across more than 3,500 sponsors.

Study Design is part of Advarra's broader data and AI product portfolio and is informed by the company's deep experience operating IRB and clinical trial systems. The solution is designed to align study planning with operational realities, reduce the frequency of protocol amendments, and help sponsors bring more efficient, feasible trials to sites and patients.