Executive Summary

GCP ClinPlus established a transformative decade-long partnership with a US biotech company, delivering comprehensive biostatistics and SAS programming capabilities that significantly enhanced the client's biometric operations. By strategically integrating teams across US and China time zones, we created a seamless 24-hour operational model that accelerated development timelines while reducing costs by $30 million. Our collaborative approach directly contributed to three successful FDA NDA approvals, fundamentally transforming the client's ability to bring life-changing therapies to patients.

The Challenge

1. Building Biometrics Capabilities from the Ground Up

· Client lacked robust internal biostatistical infrastructure despite ambitious development pipeline

· Inconsistent statistical methodologies and programming practices hindered regulatory readiness

· Limited internal capacity to handle the volume and complexity of data across multiple concurrent trials

2. Managing Escalating Development Costs

· Rapidly rising expenses for US-based statistical and programming resources threatened program viability

· Traditional CRO pricing models created unsustainable budget pressures for the growing biotech

· Inefficiencies in data processing and analysis created timeline bottlenecks delaying critical milestones

3. Navigating Global Time Zone Barriers

· Development delays caused by traditional sequential workflow patterns across different geographic regions

· Communication challenges between global stakeholders impacting quality and consistency

· Critical time lost during handoffs between different teams and organizations

Our Solution

1. Integrated Global Team Structure

· Strategic Resource Allocation: Deployed a balanced mix of US and China-based specialists to optimize expertise and cost efficiency

· Seamless Knowledge Transfer: Implemented comprehensive training and mentorship programs to ensure consistent methodologies

· Standardized Processes: Developed unified SOPs and templates for statistical analyses that met FDA requirements

2. 24-Hour Continuous Operations Model

· Follow-the-sun Workflow: Established overlapping work schedules across time zones enabling continuous progress

· Real-time Communication Protocols: Implemented digital collaboration tools for instant information sharing between regions

· Handoff Excellence: Created structured transition processes ensuring complete knowledge transfer between shifts

3. Cost Optimization Framework

· Hybrid Pricing Model: Designed a customized engagement approach combining FTE and milestone-based compensation

· Technology Optimization: Deployed advanced statistical computing infrastructure reducing processing time and costs

· Scalable Resourcing: Flexed team size based on project demands, eliminating overhead during slower periods

4. Quality Assurance Excellence

· Multi-level Quality Control: Implemented rigorous validation protocols exceeding FDA expectations

· Regulatory Intelligence: Applied cutting-edge statistical approaches aligned with evolving FDA guidance

· Continuous Improvement: Established metrics-driven performance evaluation identifying optimization opportunities

Achievements

· Regulatory Success: Directly contributed to three successful FDA NDA approvals through robust statistical support

· Financial Impact: Generated documented cost savings of $30 million compared to traditional US-based resourcing models

· Operational Transformation: Reduced analysis and reporting timelines by 40% through the 24-hour continuous operations model

· Quality Excellence: Maintained error rates below 1% across all deliverables, exceeding industry benchmarks

· Knowledge Transfer: Successfully transitioned key statistical capabilities to the client's internal teams, building lasting organizational capacity

Long-Term Partnership Value

The decade-long collaboration evolved from a tactical outsourcing arrangement to a strategic partnership, with GCP ClinPlus becoming an integral extension of the client's development capabilities. Our involvement expanded from early statistical consulting to comprehensive end-to-end biometrics support across the entire portfolio, demonstrating our commitment to growing alongside our partners.

Why GCP ClinPlus?

GCP ClinPlus specializes in creating customized biometric solutions that balance quality, speed, and cost-effectiveness. Our unique global operating model leverages talent across regions while maintaining seamless integration and consistent quality standards. We excel at:

· Designing efficient statistical analysis frameworks that meet regulatory requirements

· Building scalable biometrics capabilities that grow with our clients' needs

· Implementing innovative operational models that maximize resource effectiveness

By combining technical excellence, operational innovation, and deep regulatory understanding, we help clients navigate the complex landscape of drug development while optimizing their investment in critical biometric capabilities.

Contact: Suling Zhang, VP of International Operations and Business Development
 Email: suling.zhang@gcp-clinplus.com
 Phone: +1 609-255-3581

About GCP ClinPlus

With 22 years of experience, 2,200+ successful projects, and 160+ NDA approvals from FDA, NMPA, and EMA. Our US team brings 30+ years of global regulatory experience to every engagement.