Email:
global@GCP-ClinPlus.com
Biosimilar development requires precise execution—scientific rigor, regulatory compliance, and cost-effective operational planning. At GCP ClinPlus, we support global sponsors in conducting biosimilar clinical trials in China with speed, accuracy, and deep local knowledge. Our services span from clinical PK/PD bridging studies to confirmatory efficacy trials in diverse therapeutic areas.
With over 22 years of experience, a specialized biometrics team conducting 200+ PK/PD projects annually, and access to biosimilar-experienced sites, we deliver reliable data that meet the standards of NMPA, FDA, and EMA—helping our clients navigate regulatory expectations and accelerate global approvals.
China is increasingly critical in global biosimilar development due to its large patient population, evolving regulatory pathways, and cost-efficiency.
We focus on the unique success factors of biosimilar programs:
Site Selection Strategy
Prioritize sites with experience in biosimilar trials and access to reference biologics
Focus on hospitals with high patient volume and clinical infrastructure for PK sampling and immunogenicity testing
Close collaboration with site investigators to ensure protocol compliance and quality sample handling
Patient Recruitment Excellence
Leverage treatment-naïve and well-characterized patient databases
Proven success in fast enrollment through targeted feasibility, site incentives, and patient tracking tools
Rapid turnaround in high-incidence areas like oncology, rheumatology, endocrinology, and nephrology
Biometrics & PK/PD Analysis
Dedicated PK/PD statistical team with 200+ biosimilar projects/year
CDISC-compliant data management and validated programming for global submissions
In-depth support for bioequivalence (BE) assessments, anti-drug antibody (ADA) tracking, and comparative immunogenicity
Risk-Based Monitoring (RBM)
Prioritized oversight of critical variables: PK sampling timing, adverse events, and immunogenicity
Adaptive monitoring plans based on trial phase, study endpoints, and site performance
We also provide regulatory consulting, submission support (eCTD/NMPA/EMA), and biostatistics for equivalence margin justification.
Proven Experience: 22+ years in clinical development, with extensive biosimilar trial support.
PK/PD Powerhouse: 200+ PK/PD projects annually, with expert statisticians and validated tools.
Strategic Site Access: Network of hospitals familiar with reference drugs and sample handling.
Faster Enrollment: Access to treatment-naïve or characterized patient cohorts.
Risk-Focused Execution: RBM model that prioritizes biosimilar-specific endpoints.
Global-Standard Compliance: NMPA/FDA/EMA-ready data and submission support.
Cross-Functional Expertise: Clinical, regulatory, medical, and statistical teams aligned end-to-end.
Accelerate your biosimilar program with confidence—GCP ClinPlus delivers science-driven, audit-ready studies in China.
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.