VISIONAL™

teal square with visional

VIDEO: VISIONAL™: Study Modeling Tool From PSI CRO 

Join Emily McInturf, Director of Feasibility at PSI, in conversation with Natania Barron, Senior Director, as they discuss the newest addition to PSI’s INTELIA™ suite, VISIONAL™. VISIONAL™ is an advanced feasibility tool that helps accurately predict study enrollment timelines, beyond human ability. The tool harnesses the power of machine-learning to provide enrollment forecasting to minimize your trial’s budget, comparing hundreds of country and site combinations, and probability of success within just a few minutes.

Watch the full video to learn more about how PSI’s VISIONAL™ can help you get control over clinical trial planning, including:

  • How VISIONAL™ creates and models patient enrollment scenarios
  • What data and algorithms VISIONAL™ uses
  • How VISIONAL™ increases accurate forecasting by reducing natural biases

VIDEO: VISIONAL™: Study Modeling Tool From PSI CRO  Read More »

Case Study: How VISIONAL™ is Helping to Accurately Predict Study Enrollment Timelines

At a Glance: AI and ML-powered insights for your next trial

A sponsor of a challenging breast cancer study needed to identify the optimal mix of countries and sites with similar experience and access to a hard-to-recruit subpopulation of breast cancer. Using internal and external data sources, PSI’s VISIONAL™ platform compared thousands of feasible country-site combinations and recommended the optimal enrollment scenario to meet the sponsor’s timelines and cost constraints.

Trial Enrollment Recommendations from VISIONAL™
key metrics for VISIONAL case study. 520 patients with heart in hand symbol. 126 trial sites with a target in a human head symbol. 7 countries with a world symbol. all in white text.

Sponsor Challenges

The study targeted patients pretreated with recently approved drugs. Our key criteria for country and site selection included local standards of care, historical performance in the indication, and current competition. After the initial planning had begun, the sponsor also requested 20% of patients from Latin America.

How VISIONAL™ Helps Make Strategic Decisions

Working with internal and external data sources and KOLs, PSI feasibility team quickly pulled all available data on standards of care, site performance, and historical enrollment rates, carefully curated for similarity. The dataset included 40+ countries in North America, South America, Europe, Asia-Pacific, and Africa. Using this trove of data, VISIONAL™ compared hundreds of country/site combinations, taking into account study costs and probability of success.

We were able to easily adjust the constraints for regional patient quotas as well as additional requirements from the FDA and EMA after two rounds of protocol review.

Results

1. Optimal Enrollment Scenario

VISIONAL™ recommended the most optimal combination of sites, countries, and timelines based on the current landscape and historical benchmarks, while taking into account all constraints set by the sponsor and the FDA.

2. Cost vs. Speed
The system recommended the fastest and most cost-efficient scenario within the sponsor’s budget range and timelines. We were also able to quickly evaluate alternative options:

  • Faster scenarios with an acceptable risk level
  • Longer but less expensive scenarios
  • Scenarios that buffer for unexpected delays

3. Customizable and Adaptive Reports
The initial work done during the planning stage also provided the sponsor with peace of mind during the study launch with the ability to rapidly model new scenarios based on additional constraints/new requirements.

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Therapeutic Areas

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

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