Evinova Study Document Assistant

Clinical study teams spend weeks manually navigating thousands of pages of documentation. The Evinova Study Document Assistant (SDA) uses AI to simplify this process – reducing time, cutting costs, and improving clinical documentation workflows.

From protocol amendments to site queries and regulatory responses, SDA is purpose-built to solve documentation challenges with measurable results:

Site Queries

Study teams handle as many as 20 clinical queries per week, each taking 25–50 minutes to resolve. SDA streamlines this process, delivering an 80% reduction in navigation and query resolution time [1a] – resulting in savings between $1.5M and $15M, depending on pipeline size.

Text graphic with a colorful abstract ribbon icon. It reads: "Up to $15M in savings, depending on pipeline size. 80% reduction in navigation & query resolution time."

Protocol Amendments

76% of protocols undergo at least one substantial amendment [2] . SDA reduces the time spent identifying required revisions by 50% [1b] , with validated savings of up to $10M for large pharma and $1M for smaller sponsors.

50%

reduction in time spent identifying revisions

$10M

validated savings for large pharma

$1M

validated savings for smaller sponsors

Health Authority Responses

Regulatory queries demand extensive time and cross-referencing. SDA enables collaborative drafting and review, with an expected 70% time reduction and potential savings of $2M, depending on pipeline size and distribution.

Text graphic with a semi-circular gradient design on the right. It reads: "~70% time reduction. ~$2M potential savings."

Key features:

  • Optimized Performance

    AI model custom-trained on clinical trial documents with advanced capability to process complex study documentation such as schedule of assessments and footnotes.

  • High-Quality Answers with Source Verification

    Receive precise answers backed by verified sources, complete with highlighted references and specific citations to confirm accuracy and credibility.

  • No More Repetitive Uploads

    One-time study setup with continuous memory. Maintain source control to ensure
accurate, reliable responses built on the study documents uploaded for your
study compared to general models that pull from all available sources.

  • Human-in-the-Loop Collaboration

    Study teams review and refine AI-generated drafts to ensure compliance and accuracy.

  • Fast Setup

    Quick implementation, with complete setup and deployment in just a few weeks.

Ready to transform your clinical documentation process?

  • Select your initial number of studies

  • Expand rapidly as needed

  • Start seeing savings immediately

Contact us today to request a demo

Sources

[1a] [1b] Data from double-arm studies conducted at large pharmaceutical companies
[2] Getz, K., Stergiopoulos, S., Short, M., Surgeon, L., Krauss, R., Pretorius, S., Desmond, J., and Dunn, D.
(2016). The impact of protocol amendments on clinical trial performance and cost. Therapeutic Innovation
and Regulatory Science, 50(4), 436-441.