Therapeutic Areas

We have conducted 40+ ophthalmology trials across indications such as DME, glaucoma, and dry eye. Our clients include leading global companies like Bausch + Lomb and Santen, and we have long-standing partnerships with China's top-tier ophthalmology hospitals and KOLs.

With experience in 120+ MRCTs, we provide end-to-end support including protocol localization, bilingual project management, and global regulatory coordination. Our bilingual teams ensure alignment with FDA, EMA, and NMPA requirements.

We provide a full suite of services for FIH trials, including feasibility analysis, site selection, regulatory strategy, risk mitigation, and medical monitoring. Our early-phase team has supported FIH programs in oncology, CGT, and rare diseases.

We integrate internal therapeutic expertise with external KOL and hospital collaborations. This enables us to deliver tailored strategies and maintain high scientific and operational quality across all indications and modalities.

We supported the approval of Hope Biomedical's stem cell therapy Emistatocel, the first stem cell product approved in China (indication: SR-aGVHD post steroid failure). We've also supported 40+ CGT projects, including CAR-T trials for hematologic malignancies and stem cell therapy for retinal diseases.

GCP ClinPlus offers end-to-end regulatory support to ensure innovative therapies meet international standards. Our integrated framework includes:

• Dual-Region Regulatory Strategy – Our expert teams in both China and the U.S. co-develop regulatory roadmaps tailored for dual or multi-regional submissions (FDA, EMA, NMPA), helping sponsors align early with global authorities.

• GLP/GCLP-Compliant Bioanalysis – We partner with certified labs experienced in FDA and EMA audits to conduct method validation and sample testing that meet international guidelines.

• Global-Format Data Outputs – Our in-house biostatistics platform generates real-time outputs in formats compliant with CDISC, SDTM, ADaM, and other FDA/EMA requirements, ensuring smooth data submission and faster regulatory review.

• Regulatory Document Support – From IND/IMPD/CTA preparation to CSR writing and eCTD compilation, we provide high-quality documentation aligned with global templates.

• Audit Readiness & Oversight – We offer proactive quality oversight and readiness for regulatory inspections through mock audits and QMS support.

We deploy a full risk-control system:

• Pre-infusion: dose adjustments for patients with high tumor burden; strict QC on manufacturing

• During infusion: 24/7 monitoring for CRS/ICANS by a multidisciplinary team

• Post-infusion: dynamic cytokine and CAR-T expansion monitoring to enable timely intervention

Yes. We've supported gene therapy development for β-thalassemia and inherited retinal diseases. Our services cover vector safety assessments, long-term efficacy follow-up, and market acceleration strategies tailored for rare diseases.

GCP ClinPlus helps global sponsors fast-track clinical trial startup in China through an integrated "Three-in-One Acceleration Strategy":

• Pre-Qualified Site Network – We maintain an extensive database of vetted sites with relevant therapeutic capabilities, robust patient pool and strong collaboration, allowing rapid feasibility and faster site selection.

• Standardized Site Onboarding – We boost site readiness through centralized training programs for investigators and study teams, ensuring consistent GCP compliance and faster activation.

• Smart Oversight & Enrollment Tracking – Our proprietary digital platform enables real-time tracking of patient recruitment and automated data quality monitoring, helping you stay on schedule and avoid costly delays.

With deep local expertise and global project management standards, GCP ClinPlus bridges regulatory and operational gaps—cutting startup timelines from months to weeks.