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global@GCP-ClinPlus.com
As demand for Investigator-Initiated Trials (IITs) and advanced therapies continues to grow, biopharma sponsors frequently encounter challenges related to operational efficiency, regulatory compliance, and fragmented vendor management in China. To address these complexities and streamline the pathway from early development to clinical operations, GCP ClinPlus and ProBio Inc. announced on June 3, 2026 a strategic collaboration designed to accelerate IITs and clinical development in China, providing integrated, end-to-end solutions for global biopharma customers.
This collaboration unites the comprehensive clinical trial execution capabilities of GCP ClinPlus — spanning clinical operations, data management, biostatistics, pharmacovigilance, and regulatory affairs — with ProBio Inc.'s deep expertise in biologics and cell and gene therapy (CGT) CDMO services. The combined offering supports cutting-edge therapeutic modalities, including in vivo CAR-T, gene therapy, cancer vaccines, and gene editing therapies.
GCP ClinPlus brings over 23 years of industry experience, having successfully executed 2,300+ clinical trials and supported 220+ product approvals. The company has a proven track record in CGT and oligonucleotide therapies, with 100+ projects completed across CAR-T, stem cells, and oligonucleotides — including a pivotal role in supporting the approval of one of China's first stem cell therapies. Additionally, GCP ClinPlus was the first CRO in China to successfully support an oligonucleotide drug through FDA submission. Complementing this, ProBio Inc. contributes extensive experience in early development and translational science, having supported over 40 IIT programs across diverse CGT pipelines.
This bilateral collaboration model offers international biopharma companies a simplified entry point into China's clinical research ecosystem, reducing vendor complexity while accelerating local trial execution. As an AI-driven intelligent CRO, GCP ClinPlus integrates its proprietary Clinx platform to enhance trial predictability and efficiency, combined with ProBio's CDMO capabilities to enable data-driven decision-making.
"This strategic alliance marks an important step in supporting global innovators entering China," said Allen Guo, CEO of ProBio. "By bringing development and clinical execution closer together, we can help our clients move Investigator-Initiated Trials forward with greater speed, confidence, and simplicity."
By integrating CMC, non-clinical studies, and clinical operations into one coordinated solution, the collaboration accelerates IIT start-up timelines and enables more efficient engagement with global biotech partners, ultimately helping bring innovative therapies to patients faster.
GCP ClinPlus is a leading AI-driven, full-service CRO founded in 2003, headquartered in China with global operations. Guided by the philosophy "AI empowers every data point to illuminate hope," the company provides intelligent, efficient, and predictable clinical research solutions that meet international standards. For more information, please visit www.gcpclinplus.com.