We are on a mission to transform clinical trials.
Clinical trials have not changed in over 75 years.
Based on double-blind placebo-controlled gold standard
Trial protocol is approved by FDA up front
Trial cannot be significantly changed until complete and unblinded
Endpoints are usually some standard statistical measure of efficacy and safety
Frequentist statistics is standard
Data purity is paramount – encrypted and unblinded
TrialClarity is the new paradigm to enable adaptive clinical trials.
Preserves double blind placebo controlled gold standard
Protects data integrity through advanced technology
Utilizes cutting-edge AI/ML to monitor and analyze trial progress
Enables Bayesian inference to be utilized
Allows simulations to optimize the protocol
Facilitates Prospectively Planned Modifications and pre-specifications
Recommends adaptations not included in the initial protocol
Allows the trial to be adjusted dynamically to conform with protocol
May implement adaptations included in the protocol
Where required, prepares documentation for submission to FDA