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Study Design & Optimization

Smarter Study Design Starts Here

Clinical development is evolving from manual workflows to intelligent, AI-driven processes. Evinova's Study Designer solution empowers clinical teams to design, optimize and automate authoring and downstream systems leveraging a connected USDM data architecture. Combine AI with deep expertise to accelerate timelines, enhance site and patient experiences, and unlock significant cost savings.

“Evinova platform dashboard showing clinical trial scheduling and cost optimization. The screen displays metrics per patient, primary schedule with visit costs, and a bar chart comparing cost per patient across multiple countries.

Design with Intelligence

  • Design smarter and faster: Instantly generate and compare multiple study design scenarios while staying aligned with internal and industry standards

  • Optimize with AI: Refine eligibility criteria, endpoints, and schedules using AI agents trained on past study performance to reduce risk and improve outcomes

  • Accelerate with confidence: Focus on the metrics that matter most—delivering high-quality designs that get treatments to patients faster

Costing That Saves Millions

  • Generate robust cost estimates in minutes with over 97% accuracy, enabling confident trade-offs without compromising quality

  • Forecast costs at any stage from early ballpark costing through to full study cost estimates suitable for investment decisions

  • Create multiple cost scenarios in seconds with drill-down capability to individual cost drivers including insourced vs outsourced models, lab costs, resource costs, and country allocation

  • Work alongside your team with models that support collaborative decision-making throughout the costing process

For one large pharma customer, Evinova’s Study Designer solution delivered:

$100M
savings in the first year
$365M
by year four [1a]

Benchmarks That Raise the Bar

  • Leverage AI and data science to compare your study design against top-quartile industry and internal targets

  • Optimize for patient and site experience with sustainability and recruitment improvements requiring no extra inputs

  • Design studies that set new standards and deliver meaningful outcomes for patients, study teams, and the planet

  • Opt in to the industry-wide Total Study Cost Benchmark updated regularly by phase and indication, to quickly compare your studies against industry performance. Access these insights directly in Study Designer for a complete view in one solution.

Evinova’s Study Designer solution delivered:

~ 1 month
faster start up
30%
more performing sites
66%
more patients per site[1b]

Feasibility, Forecasted

  • Assess site, country, and patient allocation impacts before your study begins using optimization models trained on industry and your data 

  • Visualize the competitive landscape and predict country and site start-up performance based on your study design

  • Forecast recruitment performance with predictive models that optimize allocation decisions early in the planning process

Protocol Digitization 
Reimagined

  • Transform legacy protocols into machine-readable formats aligned with ICH M11 and CDISC USDM 4.0 using agentic AI

  • Automate and standardize study design across your portfolio to enable continuous improvement

  • Query existing protocols instantly to drive smarter decisions and downstream automation

Accelerated Authoring & Automation

  • Get agentic AI recommendations across scientific, medical, regulatory, and operational domains from protocol to informed consent

  • Ensure strategic alignment with models that work with your standard libraries and organizational strategy

  • Build trust in AI models by easily checking the quality of recommendations directly within the solution

  • Export designs in any format directly into downstream systems, accelerating delivery with confidence and saving teams hundreds of hours

Ready to Optimize?

Along with your expert study teams, Evinova’s Study Designer solution is a partner in reimagining study design.
Unlock faster, more cost-effective clinical trials.

Contact Us Today

Sources

[1a] [1b] Evinova data on file