In-silico Trials

Accelerate drug development with synthetic clinical trials

At Biotrial, we leverage 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 influence study designs and reduce development costs, improve patient safety, and speed up decision-making across clinical development.

 

Biotrial_Datascience_in_silico_trials
Biotrial_datascience_in_silico_trials

What are In-Silico Trials?

In Silico trials use computer-simulated environments to model how a drug interacts with the human body. These simulations are built on biological, pharmacological, and clinical data, allowing researchers to forecast outcomes such as efficacy, safety, dosage 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, but they also hold strategic value for any trial where the team wishes to reduce risk and increase the confidence in choice of dose, in/ex 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 the trial begins
  • Tailor inclusion/exclusion criteria to target patients more effectively

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

Added values

clinical

Accelerate clinical development

Reduce timelines by identifying potential failures early and adjusting trial designs in advance

Money Management

Cost efficiency

Limit unnecessary recruitment, site costs, and amendments

ethical

Ethical advantage

Minimize exposure of patients to ineffective or harmful treatments

regulatory

Regulatory alignment

Our simulations meet industry standards and support regulatory expectations for model-informed drug development (MIDD)

Participate in a clinical trial

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