Expert Clinical Research

Advancing Pediatric Health Through Clinical Excellence

Pediatric Pathways Clinical Consulting provides expert support in planning, coordinating, and optimizing pediatric clinical trials with over 25 years of experience in FDA-regulated studies.

Jiangyu Sun - Clinical Research Professional
25+
Years Experience
2
Professional Certifications
FDA
Regulated Studies
100%
Compliance Focus

Jiangyu Sun

With a distinguished career spanning from Duke University Medical Center to St. Jude Children's Research Hospital, Jiangyu brings unparalleled expertise in pediatric clinical research coordination.

Her deep understanding of complex protocols and regulatory compliance ensures that every trial delivers high-quality data that advances pediatric health outcomes.

CCRC - Certified Clinical Research Coordinator

Association of Clinical Research Professionals (ACRP) — Demonstrates proficiency in core clinical research coordinator duties.

CCRP - Certified Clinical Research Professional

Society of Clinical Research Associates (SOCRA) — Validates knowledge and skills in FDA-regulated drug/device studies.

Comprehensive Clinical Trial Support

From protocol development to regulatory submission, we provide end-to-end support for your pediatric clinical trials.

Protocol Development

Expert guidance in designing robust, compliant protocols that meet FDA requirements while optimizing for patient safety and data quality.

  • Protocol writing & review
  • Feasibility assessments
  • Risk-benefit analysis

Trial Coordination

Seamless management of all trial operations, ensuring timelines are met and quality standards are maintained throughout the study lifecycle.

  • Site management
  • Patient recruitment support
  • Data collection oversight

Regulatory Compliance

Navigate complex FDA regulations with confidence. We ensure your trials meet all GCP and GxP requirements for successful submissions.

  • FDA submission support
  • IRB coordination
  • Audit preparation

Revolutionize Your Clinical Trials with AI

We integrate cutting-edge Artificial Intelligence to transform your clinical operations, turning legacy challenges into competitive advantages.

12+
Months of Trial Acceleration
170x
Faster Patient Identification
96%
Patient Matching Accuracy
40%
Reduction in CSR Authoring Time

Cross-Border Clinical Research Excellence

Leveraging deep expertise in both U.S. FDA and international regulatory landscapes, we help sponsors navigate the complexities of global clinical trials, particularly in gene therapy and pediatric research.

Our cross-border capabilities enable faster trial execution, broader patient recruitment, and seamless regulatory submissions across jurisdictions.

  • FDA Regulatory Expertise
  • International Trial Coordination
  • Gene Therapy Trials
  • Rare Disease Research
  • Pediatric Oncology
  • Data Management

United States

FDA-regulated trials with rigorous GxP compliance

Global

International partnerships & expedited pathways

Ready to Advance Your Research?

Schedule a consultation to discuss how we can support your pediatric clinical trials.

Schedule Your Consultation