Finally, take control of clinical trial planning
The feasibility platform built to protect your clinical trial from delays and budget overruns
As a biopharma sponsor, you face the pressure to get your promising therapy to patients as quickly and responsibly as possible. Delays and change orders don’t just disrupt timelines – they put funding, teams, and momentum at risk.
It’s hard enough to get your vision funded. Why do you have to plan for budget overruns as if they are inevitable? You deserve accurate timelines, controlled budgets, and early insight into whether your drug works.
PSI was founded 30 years ago to address exactly this challenge. We built our operational model around predictable delivery. VISIONAL™ is the latest extension of that commitment – giving you real-time visibility into study progress before issues are identified or delays occur.
The result: Studies that stay on track, budgets that hold, and faster answers for the patients waiting.
AI-powered Feasibility Analysis
SOC
Site performance data
Available patient pool
Enrollment rates
Startup data
…
Client/PSI-driven Constraints
- Optimal scenario + budget
- Most probable scenario + budget
- Cost-efficient scenario + budget
- Fastest scenario + budget
- Custom scenario(s) + budget(s)
VISIONAL™ is the only platform in the industry that integrates both financial and clinical feasibility with AI and machine learning to help you with decision-making.
Using over a dozen internal and external data sources, VISIONAL™ models and compares hundreds of enrollment scenarios, their budgets, and the probability of success for your protocol.
For your protocol, it can quickly:
- Provide an optimal clinical trial plan that balances out the associated cost and study duration
- Find the fastest feasibility solution that expedites your FPI and LPI
- Identify the most cost-efficient scenario that matches your budget and constraints
- Model the cash flow for your protocol or portfolio
- Estimate the probability of success for expected scenarios and recommend alternatives
- Validate your requested specifications
What are the benefits for our sponsors?
- Faster decisions: VISIONAL™ has the capacity to model and compare hundreds of possible enrollment scenarios and suggest the most optimal scenario within only a few minutes
- Live budget simulations: It’s the only platform that combines clinical and financial feasibility. For budget predictions, we trained our algorithms on the data from CLARITY™, PSI’s study budgeting and forecasting solution. Each model comes with a budget accurately calculated to match your specifications
- Predictions without human error or bias: VISIONAL™ debiases projections; scenarios are automated and data-driven. The algorithms are based on the latest data and are retrained on an ongoing basis
- Probability of success built in: VISIONAL™ enables you to choose a scenario that aligns with your risk tolerance, within feasible ranges
Immediate & Long-Term Benefits
Challenge
The sponsor was preparing a pivotal program – one of the largest in the industry. Two competitors were already ahead. To win the race to the market, the sponsor needed a plan that was fast and realistic.
Solution
The sponsor’s priority was clear: identify the right country and site strategy to accelerate LPI without exceeding budget or increasing risk.
Using similarity search in VISIONAL™, PSI quickly pulled data for 63 countries with relevant industry experience:
- The data incorporated standards of care and local access to required treatments, site interest from the sponsor’s phase 2b, and country-specific startup timelines and known regulatory contraints
- The site and enrollment data included performance metrics for similar designs and indications, as well as additional data from some of the industry’s longest databases
- PSI’s medically trained feasibility team validated the selection to ensure it’s relevant to the protocol design
With LPI timing and budget as fixed constraints, PSI modeled dozens of feasible scenarios and identified those with the highest probability of success.
Outcome
VISIONAL™ enabled the sponsor to compare several feasible options side by side – lower cost versus higher cost, lower risk versus higher certainty – and select the strategy that best fit their goals.
Once the study launched, live site-identification data continuously updated the model, enabling real-time adjustments while keeping LPI and budget as fixed constraints.
Site activation and enrollment are on schedule, with the LPI firmly in sight, positioning the sponsor to beat competitors to market without budget overruns.
As I see the phase 3 studies kick into activation, I just wanted to reach out and say how happy I am that we were able to get PSI on these studies. Do your magic!
Learn more about our relentless innovation to deliver clinical trials on time and on budget
SYNETIC™
Site and study knowledge engine
PSI proprietary cloud-based platform
VISIONAL™ is part of PSI’s award-winning INTELIA™ platform, a suite of advanced tools for clinical trial planning and conduct.
INTELIA™ brings together a suite of clinical trial planning tools:
- SYNETIC™ site and study knowledge engine
- VISIONAL™ financial and clinical feasibility modeling
- CLARITY™ study budgeting and forecasting
- CADENCE™ study budget tracking and reporting
- INSITE™ investigator grant calculator
- PACE™ smart monitoring planning
Take Clinical Trial Planning to a New Level of Dependability
Model your study or portfolio early. Compare study designs, regions, and enrollment options. Evaluate risks and forecast portfolio costs – all in minutes.
PSI and ITM at SCOPE 2026
Learn how sponsors like ITM plan their portfolios using accurate feasibility and financial data. Join us at SCOPE 2026 on February 4th at 11:15 am for Clinical and Financial Feasibility in One: PSI and ITM.
- February 4th, 11:15 am EST, Outsourcing Track
Case Study: How VISIONAL™ is Helping to Accurately Predict Study Enrollment Timelines