Email:
global@GCP-ClinPlus.com
GCP ClinPlus provides comprehensive early-phase clinical development services in China, offering global biopharma and biotech companies a reliable and cost-effective pathway for first-in-human and proof-of-concept studies. With over 22 years of experience, over 2,200 projects completed, and 210+ product approvals, we are trusted by clients worldwide for our speed, scientific rigor, and data quality. Our expertise spans multiple therapeutic areas, including oncology, cell and gene therapy, and rare diseases. Backed by deep regulatory knowledge and strong partnerships with NMPA-accredited early-phase units, we help sponsors generate high-quality data that meets FDA, EMA, and NMPA standards—accelerating global development.
Early-phase clinical trials are pivotal in shaping the success of any drug development program. These studies help establish safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and initial efficacy signals—serving as a foundation for future phases. Conducting early-phase studies in China offers international sponsors strategic benefits, including access to a large patient population, efficient timelines, and significant cost savings.
We work closely with top-rated early-phase clinical pharmacology units across China, many of which offer green channel capabilities for faster study start-up. Our end-to-end support includes:
Pre-IND consulting and study design
Regulatory strategy and NMPA submissions
Site identification, contract negotiation, and activation
Medical monitoring, PV, and data safety oversight
Full-service biometrics including data management, biostatistics, and programming
Our teams include former FDA reviewers, PhD-level statisticians, and CGT experts who ensure global regulatory compliance and data credibility. For companies exploring novel modalities—including biologics, RNA-based therapeutics, and cell/gene therapies—our scientific leadership and operational flexibility provide added value.
Whether you aim to generate first-in-human data, conduct PK bridging for global submission, or assess proof-of-concept in Chinese populations, GCP ClinPlus offers a trusted, streamlined, and science-driven solution.
Global-Standard Compliance: FDA/EMA/NMPA-aligned data and processes.
Cost-Effective: Up to 50–80% savings vs. U.S./EU trials.
Faster Start-Up: 30% shorter timelines via green channel and strong SSU team.
Strategic Insight: Regulatory, clinical, and scientific expertise under one roof.
Scientific Credibility: Trusted by leading biotechs for first-in-class therapies.
Robust Site Network: Access to China's top early-phase units and hospitals.
End-to-End Support: From pre-IND to study close-out with full project ownership.
Client-Centered: Agile, responsive, and dedicated to your trial’s success.
GCP ClinPlus delivers exceptional expertise with genuine commitment to our projects. Their team demonstrates remarkable responsibility at every stage, consistently going above and beyond. In an industry where dedication matters, they've proven themselves an invaluable partner for our success.
After enrollment challenges with our previous CRO threatened our study timeline, GCP ClinPlus stepped in and transformed our project. Their team rapidly accelerated patient recruitment beyond our expectations and put our critical study back on track. Their clinical expertise and swift implementation proved decisive in securing our study's success.
GCP ClinPlus stands out for their exceptional responsiveness and customer focus. Their team consistently prioritizes our needs with prompt, thoughtful solutions to every challenge. Their combination of technical excellence and client-centered approach makes them a truly strategic partner in our development programs.