Harnessing the Power of Data for Precision Healthcare
Central lab
Clinical trial design and consultation
Regulatory submission and consultation

Central Lab Services

Basic Research & Early Discovery
Assay development
& screening
High throughput
screening
Full pathology
& molecular services
Digital imaging
solutions
Pharmaceutical FDA Regulatory Affairs
  • IND, NDA, DMF,
    CMC writing, eCTD publishing
  • Safety Monitoring
  • IVD Devices
  • NIOSH Certification,
    EUA and 510(k)s
Drug Development Pathway
In Vitro and In Vivo Testing
Human Testing
Volunteers Data Review Surveillance
10s-> 100s -> 1000s
Data Review
Surveillance
What is the best clinical development
pathway to approval?
1
Track competitor activity
and strategies
2
Optimize clinical trial planning
and execution
3
Identify and reduce risk in your
drug portfolio
Who benefits?
Head of R&D, Clinical Operations, Program Management,
Competitive Insights & Analytics Head
We provide customized research and analysis that transforms information on clinical trials, drugs and sites into actionable intelligence
for your organization.

From helping you visualize your future competitive landscape to improving your chances of running a successful clinical trial, this service provides the tools you need for effective decision making.
Leadership Team
  • Fei Chu, MD, PhD
    Director of Biopharma
    Dr. Fei Chu is principal investigator and professor of RUSH University Medical Center. He received his MD from Zhengzhou University Medical School and PhD in Pathology from Beijing University of Chinese Medicine.
  • Jim Lu, MD, PhD
    President, CEO and Medical Director
    Dr. Lu holds degrees from Wannan Medical College in
    China and Johns Hopkins Medical Institute in
    Baltimore, Maryland. After completing his pathology
    residency at UPMC, he pursued a specialized
    fellowship in Liver, GI, and transplant pathology under
    the guidance of Drs. Demetris and Finkelstein at the
    same institute.
  • Jiaxin Niu, MD, PhD
    Director of Head and Neck Medical Oncology
    Dr. Jiaxin (Jason) Niu, MD, PhD, serves as the
    Director of Head and Neck Medical Oncology and
    Thoracic Medical Oncology at the Banner MD
    Anderson Cancer Center at Banner Gateway Medical
    Center. He initiated his medical journey at China
    Medical University, where he completed his medical
    education and a residency in General Surgery.
  • Guoyou Cai
    MSc, RAC, Head of Regulatory Affairs
    Guoyou (Gary) Cai is a seasoned regulatory affairs
    expert with over 18 years of experience across the US,
    Canada, and China's pharmaceutical and medical
    device sectors. His professional interactions span key
    regulatory agencies like FDA, Health Canada,
    and EMA.
  • Hao Luo, PhD
    Deputy Director
    Dr. Hao Luo is a distinguished scientist with an
    expansive background in molecular biology. He
    earned his master’s degree in Analytical Chemistry
    from Tsinghua University and a PhD in Biochemistry
    and Molecular Biology from Baylor College of
    Medicine. With over a decade of experience in cancer
    biology research, he transitioned to our company in
    2015, progressing from a Research Scientist to the
    role of Deputy Director.
  • Qiuyang Zhang, MD
    Founder/CEO of the Council For US-China Medical Technology Exchange
    Dr. Qiuyang Zhang has created over 260 educational programs in the US and China over the course of 13 years. He is also a founding member of the Changchun Glory Hospital, which provides 120 beds and 260 staff to patients in need. Dr. Zhang received his MD from Changchun Traditional Chinese medicine University and completed his residency at the Northwestern University Feinberg School of Medicine.
How it works?
  • Discovery
    Preclinical

    Precision Medicine and Companion Diagnostics Commercialization:
    • Clinical trial specialty testing support
    • Assay development and validation
    • Specialized biomarker testing
    • Evaluation of drug efficacy
    • Project and data management services
    • Kitting services
    • Mobile phlebotomy

    Preclinical: IVD and Biopharma Specialty Lab Services:
    • Method development
    • Analytical testing 510 (k) and PMA
    • CAP/CLIA testing services
    • Postapproval studies
    • Biorepository services
    • Mobile phlebotomy
    • End-to-end solutions
    • Pre-launch medical communications and proficiency paring
    • Commercial testing
    • Assay development, validation, and scale-up
    • Mobile phlebotomy
    • Sponsored testing and REMS programs

    Pharma Data Services:
    • Prevalence
    • Competitive landscape
    • Demographics
    • Comorbidity conditions
    • Biomarker/CDx development
    • by region and/or population
  • Clinical Trials
    Phases I -III, Prelaunch

    Precision Medicine and Companion Diagnostics Commercialization:
    • Clinical trial specialty testing support
    • Assay development and validation
    • Specialized biomarker testing
    • Evaluation of drug efficacy
    • Project and data management services
    • Kitting services
    • Mobile phlebotomy

    Phase I-III: IVD and Biopharma Specialty Lab Services:
    • Method development
    • Analytical testing 510 (k) and PMA
    • CAP/CLIA testing services
    • Postapproval studies
    • Biorepository services
    • Mobile phlebotomy
    • End-to-end solutions
    • Pre-launch medical communications and proficiency paring
    • Commercial testing
    • Assay development, validation, and scale-up
    • Mobile phlebotomy
    • Sponsored testing and REMS programs

    GoPath Trials:
    • Site/PI validation and identification
    • Confirmed patient population
    • Patient engagement and enrollment
    • Physician validation and outreach
  • Commercialization
    Post-market and Phase IV

    Precision Medicine and Companion Diagnostics Commercialization:
    • Clinical trial specialty testing support
    • Assay development and validation
    • Specialized biomarker testing
    • Evaluation of drug efficacy
    • Project and data management services
    • Kitting services
    • Mobile phlebotomy

    Pharma Data Services:
    • Recommended changes
    • to marketing or intervention
    • Competitive response and performance
    • Real-world and post-commercialization
Discovery
Clinical Trials
Commercialization
  • Clinical trial specialty testing support
  • Assay development and validation
  • Specialized biomarker testing
  • Evaluation of drug efficacy
  • Project and data management services
  • Kitting services
  • Mobile phlebotomy
  • Method development
  • Analytical testing 510 (k) and PMA
  • CAP/CLIA testing services
  • Postapproval studies
  • Biorepository services
  • Mobile phlebotomy
  • End-to-end solutions
  • Pre-launch medical communications and proficiency paring
  • Commercial testing
  • Assay development, validation, and scale-up
  • Mobile phlebotomy
  • Sponsored testing and REMS programs
  • Prevalence
  • Competitive landscape
  • Demographics
  • Comorbidity conditions
  • Biomarker/CDx development
  • by region and/or population
  • Recommended changes
  • to marketing or intervention
  • Competitive response and performance
  • Real-world and post-commercialization
  • Site/PI validation and identification
  • Confirmed patient population
  • Patient engagement and enrollment
  • Physician validation and outreach
Preclinical
Phase I
Phase II
Phase III
Prelaunch
Post-market and Phase IV
Precision Medicine and Companion Diagnostics Commercialization
IVD and Biopharma Specialty Lab Services
Pharma Data Services
Pharma Data Services
GoPath Trials