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In-Silico Trials

Accelerate drug development with clinical trials

At Biotrial, we harness the power of In-Silico trials—also known as synthetic clinical trials—to simulate and predict the performance of drugs and medical interventions using advanced computational modeling. These digital simulations help shape study designs, reduce development costs, improve patient safety and speed up decision-making across clinical development.

We view In-Silico trials not as a replacement for real-world studies but as a powerful complement. They pave the way for a new era of model-informed decision-making in the pharmaceutical industry and provide valuable support in interactions with regulatory authorities.

What are In-Silico Trials?

In Silico trials rely on pharmaceutical modeling. They are powered by Artificial Intelligence, Pharmacokinetics, Pharmacodynamics, Quantitative Systems Pharmacology and Statistics. They use computer-simulated environments to model how a drug interacts with the human body. These simulations are built upon biological, pharmacological and clinical data, enabling researchers to predict outcomes such as efficacy, safety, dose-response and adverse effects-providing insights before actually running the trial.

Typical use cases for In-Silico Trials

In Silico trials are especially valuable when real-world or randomized clinical trials are limited by practical or ethical constraints. They also hold strategic value for any trial where the team wishes to reduce risk and increase the confidence in choice of dose, inclusion/exclusion criteria or choice of endpoints. Common use cases include:

Rare diseases where recruiting sufficient patient populations is challenging.
Specific subpopulations such as obese patients, infants, pregnant women or patients with impaired hepatic or renal function.
Ethical concerns, e.g., when withholding active treatment may pose an unacceptable risk.
Risk estimation between trial phases (e.g., transition from Phase I to Phase II or from Phase II to Phase III).
Dose selection for Phase II or Phase III

These applications allow sponsors to gather critical data where traditional studies fall short.

Biotrial In-Silico services

Clinical trial simulation & design optimization

Biotrial offers detailed trial simulations that model patient variability, dosing schedules and treatment responses. This allows sponsors to:

Optimize trial protocols for higher efficiency and success rates
Reduce the number of required patients
Identify potential risks before trial initiation
Leverage and combine all available data from in vitro to human studies
Tailor inclusion/exclusion criteria to better target intended patient populations.

Data amplification

When data is incomplete or limited (e.g., small populations, rare diseases), our models can simulate missing data points, enabling:

Better informed go/no-go decisions
More robust conclusions in early-phase trials
Smoother transitions into pivotal studies

Benefits of In-Silico trials

Gain valuable insights: Generate supplementary data to predict how your investigational product performs in varying populations to help guide decision-making.
Accelerate clinical development: Shorten timelines by identifying potential failures early and refining trial designs ahead of time.
Cost efficiency: Minimize unnecessary recruitment, site costs and protocol amendments.
Ethical advantage: Minimize exposure of ineffective or harmful treatments to patients.
Regulatory alignment: Our simulations meet industry standards and support regulatory expectations for model-informed drug development (MIDD).