Services

CLINICAL TRIAL

Specialize in novel and pragmatic approaches for designing clinical trials, and aim to transform the early-phase drug development with forward-looking vision and cutting-edge statistical methods.

BIOINFORMATICS

We possess expertise in cancer genomics, computational biology, and bioinformatics.

Precision Medicine

We provide powerful precision medicine approaches to enable precise subgroup findings for clinical trial data.

Artificial Intelligence

Laiya provides advanced analytics models, including deep neural networks, machine learning, and Bayesian models for solving big/small data problems in health and non-health fields.

Clinical Trial Designs

Phase I Clinical Trial

  • Single-Agent Dose-Finding Design
  • Rapid Patient Enrollment
  • Immune Oncology Trial Design
  • Dose Cycle Dose-Finding Design

Phase I/II Clinical Trial

  • Drug Combination Dose-Finding Design
  • Adaptive Dose Insertion
  • Phase I-II Seamless Design
  • Multiple Cohort Expansion Design

Phase II Clinical Trial

  • Subgroup Analysis and Enrichment Design

Others

  • Real World Data/Evidence Modeling and Design

Consultation Services

Trial Design

  • Customized trial designs for each client with computer simulations
  • Simulation model tuning and simulation results analysis
  • Generation of simulation results report
  • Write up of the protocol statistical section based on simulation results report

Trial Conducting

  • Draft of the protocol statistical section (Only for design related analysis)
  • Cooperation with CRO, PI and sponsor to execute clinical trial designs
  • Adaptive decision making based on interim data analysis
  • Statistical analysis plan and study reports (Only for design related analysis)
  • Go/No-Go decision

communication & training

  • Communication with FDA, CDE, PI and sponsors
  • Trainings on adaptive designs for the sponsors and CRO

Others

  • Statistical review of the protocol
  • Review of clinical study report
  • Adaptive randomization of patient enrollment
  • Other adaptive processes, such as sample size re-estimation

About US

LAIYA is an innovative and intelligent solution provider for new drug development. We specialize in Bayesian adaptive designs and implementation for drug and device clinical trials. Our mission is to develop the best-in-class adaptive designs, strategies, and integrated software platforms to lower the risk of clinical trial failure, improve the probability of success, accelerate the development process, and maximize portfolio returns.

Founded by a tenured professor of University of Chicago, Laiya has been a leading innovator in the application of Bayesian adaptive designs to clinical trials. Our team of world class Bayesian statisticians include PhDs from University of Texas, Fudan University and Rice University. Our work was published in top journals such as Nature Methods, Journal of Clinical Oncology, Journal of the National Cancer Institute, and has won several international awards:

  • ISBA Mitchell Prize
  • 1st Place Winner in the 2018 JSM Biopharmaceutical Section Student Paper Award
  • Top 10 ideas in Precision Medicine Challenge organized by Harvard Business School

Laiya found wide recognition not only in the academic field but also in the industry. Many of its research initiatives have been developed into successful commercial products that were adopted by well-known global pharmaceutical companies, and FDA has approved clinical trial protocols incorporating these products.

Products

U-Design

U-Design is a web-based next-generation statistical and informatics tool kit for Phase I clinical trial design

BEST

The Bayesian early-phase seamless transformation (BEST) platform provides a fast, efficient, and powerful solution for early-phase drug development.

mTPI-2

Modified Toxicity Probability Interval Design Version 2

R-TPI

Rolling Toxicity Probability Interval Design

PITE

Probability Interval Design based on both Toxicity and Efficacy

MUCE

Multiple Doses/Multiple Indications Cohort Expansion

COMBO

Dual-agent Drug Combination Dose Finding Design

SCUBA

Subgroup Cluster Based Bayesian Adaptive Design for Precision Medicine

Our Team

Yuan Ji
Yuan Ji
Founder
Internationally known for his work on Bayesian adaptive designs for clinical trials and  immune oncology studies. He has published over 100 peer-reviewed papers in top journals across different scientific disciplines, including Nature Methods, JCO, JNCI
Ping Liu
Ping Liu
Co-founder, CEO
Over 15 years experience working in academic and industrial environments, applying biostatistical approaches for solving real-world biomedical problems, as well as expediting drug/medical device development.
Wentian Guo
Wentian Guo
Chief Statistician
The lead author of several highly innovative and powerful Bayesian approaches for designing early phase clinical trials.
Meng Lan
Meng Lan
Chief Technology Officer
Meng has extensive experiences in software development, especially in the field of healthcare IT. In the last 10 plus years, Meng has assumed technical leadership roles in healthcare consulting projects and healthcare institutions in US, and co-founded a healthcare startups as CTO in China.
Shengjie Yang
Shengjie Yang
Bioinformatic Scientist
Dr. Shengjie Yang has extensive clinical trial design and data analysis experience and developed a clinical statistical web application adopted by nearly 100 pharmaceutical companies and research institutions.
Jiaying Lyu
Jiaying Lyu
Senior statistician
Jiaying Lyu has published several papers on top journals about Bayesian adaptive design for early phase trials and won the first prize of 2018 JSM Biopharmaceutical Section’s Student Paper Award.
Peter Mueller
His research accomplishments include the development of novel probability models for non-parametric Bayesian inference, principled Bayesian multiplicity adjustments, simulation-based approaches to Bayesian decision problems, and innovative Bayesian clinical trial designs.

Cases & Publication

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