GCP ClinPlus Supports New Indication for Nasopharyngeal Cancer Therapy
The Challenge
In the fast-paced field of oncology drug development, the addition of a new indication often presents complex regulatory, operational, and scientific challenges. In late 2024, our sponsor sought to expand the approved use of a monoclonal antibody therapy for nasopharyngeal carcinoma (NPC) by demonstrating efficacy in combination with standard chemotherapy (gemcitabine + cisplatin) as a first-line treatment.
· Coordinating mid-study data review and decision-making across multiple sites and stakeholders
· Meeting tight regulatory timelines for submission within one month of last patient visit
· Ensuring scientific and statistical rigor in the interim analysis to support final submission
· Aligning internal and external teams on safety oversight and risk-based decisions
GCP ClinPlus Solution
A. Clinical Governance & Expert Coordination
1. IDMC Formation & Oversight: Led the establishment of the Independent Data Monitoring Committee (IDMC), recruiting experienced oncology experts and managing the full operational lifecycle.
2. Expert Liaison: Maintained continuous communication among sponsor clinical leads, investigators, and IDMC members.
B. Interim Analysis Execution
3. Data Strategy Design: Collaborated to define endpoints, analysis timelines, and data cut-off strategies.
4. Execution & Quality Review: Delivered interim statistical outputs under blinded and unblinded workflows.
5. Cross-Functional Integration: Ensured stakeholder alignment on outcomes and documentation needs.
C. Operational Delivery & Submission Readiness
6. Submission Planning: Coordinated timelines to finalize outputs and decision memos within deadlines.
7. Data Quality Assurance: Implemented multi-level QC process to maintain submission-readiness with <1% deviation rate.
8. Regulatory Support: Provided documentation and meeting support essential for NMPA review.
Achievements
· Regulatory Milestone: Contributed to NMPA approval in January 2025 for first-line NPC treatment.
· Timeline Acceleration: Enabled submission within 30 days of last patient visit, surpassing industry norms.
· Quality Performance: Delivered deliverables with <1% error rate, supporting a seamless review.
· Stakeholder Confidence: Maintained high engagement with IDMC and sponsor teams.
Strategic Partnership Value
This project reinforced GCP ClinPlus’s reputation as a trusted partner for high-stakes oncology programs. By combining governance expertise, real-time execution capability, and global communication fluency, we helped the sponsor de-risk a critical indication expansion and accelerate access to life-saving therapy for NPC patients.
Ready to Accelerate Your Clinical Success?
Whether you're preparing for a pivotal submission or building scalable trial operations, GCP ClinPlus is here to support your growth. Our global team delivers the agility, expertise, and quality you need to navigate today’s clinical development landscape with confidence.
Contact:
Suling Zhang, VP of International Operations and Business Development
Email: suling.zhang@gcp-clinplus.com
Phone: 609-255-3581