GCP ClinPlus delivered comprehensive biostatistical services for an innovative oral  targeted therapy inhibiting cancer cell proliferation, specifically developed for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Our end-to-end biostatistical support accelerated the product's market approval through the NMPA and FDA Fast Track pathways, establishing a new benchmark for Chinese-developed innovative drugs in the global market.

The Challenge

1. Navigating Unpredictable Clinical Trial Risks

· Frequent regulatory guideline updates during the boom phase of innovative drug development created significant uncertainties

· Inconsistent standardization in Chinese-localized CDISC translations complicated data structure compatibility with global requirements

2. Overcoming Technical Limitations

· Legacy data analysis tools inadequately supported aggressive project timelines, causing communication delays and extended delivery timelines

· Sponsor demanded exceptional quality standards for result presentations, including precise graphical aesthetics and strict adherence to deadlines

Our Solution

1. Advanced Project Management Framework

· Process & Tool Optimization: Enhanced and standardized 10+ internal workflows and tools to align perfectly with CDISC standards and client requirements

· Proactive Risk Control: Conducted 40+ technical workshops to ensure ongoing compliance with rapidly evolving regulatory guidelines

· Timeline Discipline: Implemented strict milestone monitoring for data query resolution and quality control submissions

2. Excellence in Service Delivery

· PDCA Methodology: Deployed Plan-Do-Check-Act cycles throughout the project to continuously improve efficiency and quality

· Knowledge Leadership: Compiled and published CDISC Chinese localization best practices at industry conferences, positioning GCP ClinPlus as a standards leader

3. Operational Excellence

· Cross-functional Collaboration: Mobilized 62 specialists across data management, biostatistics, and programming to support 162+ IND/NDA submission components

· Exceptional Resource Commitment: Dedicated 17,766+ working hours (including 1,200+ overtime hours) to ensure on-time delivery without compromising quality

Achievements

· Global Recognition: Supported the first fully China-developed innovative drug to receive FDA Orphan Drug Designation, enhancing international confidence in China's R&D capabilities

· Regulatory Success: Secured both NMPA and FDA Fast Track status, creating a new regulatory benchmark for Chinese biopharmaceutical companies

· Accelerated Approval: Achieved 2020 approval based on single-arm trial data in oncology—establishing a landmark case for accelerated approval pathways in China

· Technical Excellence: Delivered zero-error, high-precision statistical reports meeting all NDA requirements within aggressive timelines

Why GCP ClinPlus?

As an international CRO fully aligned with ICH standards, GCP ClinPlus delivers comprehensive clinical research services across diverse therapeutic areas. While this case highlights our success in oncology and immunology, our expertise extends to numerous fields including cell therapy, cardiovascular, neurology, rare diseases, and traditional pharmaceutical products.

Our team specializes in:

· Rapidly assessing and reorganizing troubled projects

· Implementing strategic recovery plans to overcome existing delays

· Transforming behind-schedule studies into successful, timely completions

Our integrated approach combines regulatory expertise, quality assurance, and sophisticated project management to rescue challenged studies and help innovative therapies reach patients faster without compromising safety or efficacy.