Email:
global@GCP-ClinPlus.com
At GCP ClinPlus, we provide comprehensive support for Investigator-Initiated Trials (IITs) in China—an increasingly strategic option for global biopharma companies. With over 22 years of clinical research experience and more than 100 IITs successfully conducted, we specialize in oncology, rare diseases, and advanced therapies, including cell and gene therapy. Our strong regulatory expertise, deep local knowledge, and trusted collaborations with leading investigators enable international sponsors to generate high-quality clinical data efficiently and cost-effectively. Whether you're seeking to explore new indications, generate first-in-human (FIH) data, or access China's large patient population, our IIT services offer a flexible and powerful path forward.
Investigator-Initiated Trials (IITs) in China offer global biopharmaceutical and biotech companies a unique opportunity to accelerate early-phase research, explore new indications, and engage in cutting-edge clinical science in a cost-effective and flexible manner. Unlike traditional sponsor-initiated studies, IITs in China can follow different regulatory pathways, making them particularly attractive for studies where speed, innovation, and scientific exploration are priorities.
Our team brings over 22 years of CRO experience, backed by robust regulatory knowledge and well-established connections with China’s top academic centers, hospitals, and leading investigators. These relationships are essential for the success of IITs, particularly when navigating protocol design, hospital ethics committees, and patient enrollment strategies.
We offer end-to-end IIT support, including:
Feasibility assessment & protocol review
Site and PI identification and engagement
Budget negotiation and site contracting
Regulatory guidance for different IIT pathways
Project management, monitoring, data management, and medical writing
Our in-house medical experts and regulatory specialists, including experienced physicians and PhD-level scientists, ensure high-quality study design and execution. For international companies aiming to generate first-in-human data, explore regional variations, or support global submissions, IITs in China provide a high-value approach—with GCP ClinPlus as your partner on the ground.
Proven Experience: 100+ IITs conducted across major therapeutic areas, especially CGT and rare diseases.
Deep Local Insight: Longstanding relationships with top-tier investigators and academic hospitals.
Regulatory Expertise: Clear understanding of China's evolving IIT regulatory framework.
Cost-Effective Execution: Faster patient enrollment and reduced trial costs compared to Western markets.
Scientific Credibility: Trials led by respected local KOLs conducting frontier research.
Comprehensive Support: From feasibility to publication, backed by a seasoned CRO with over 22 years of operational excellence.
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.