Clinical Development Strategy & Regulatory Support
GCT-tailored strategies and end-to-end IND filing services to ensure scientific integrity, compliance, and accelerated timelines.
Clinical Strategy & Protocol Design
Specialized early-phase trial design and dose-escalation strategies for cell and gene therapy products.
- GCT-optimized early clinical trial design
- Dose escalation & optimization models
- Clinical development roadmap & planning
- Patient population & eligibility criteria design
- Endpoint selection & statistical analysis plan
IND Filing Support
Full-spectrum IND preparation, dossier assembly, submission, and regulatory agency interactions.
- IND dossier writing & compilation
- Pharmacology/toxicology documentation
- CMC preparation & review
- Regulatory agency communication
- End-to-end submission project management
Clinical Operations Management
Professional and efficient full-cycle trial management to ensure quality, timelines, and risk mitigation.
End-to-End Trial Management
From site feasibility, ethics submission, patient enrollment, monitoring to study close-out.
- Site selection & initiation
- IRB/IEC submission & communication
- Patient recruitment & enrollment management
- Clinical monitoring & on-site management
- Study close-out & archiving
Site & Investigator Management
Leveraging an extensive GCT investigator network to activate high-quality sites efficiently.
- GCT-focused investigator network
- Site qualification & selection
- Site quality & performance monitoring
- Performance optimization & oversight
- Multi‑site coordination & management
Vendor & Budget Management
Strategic management of third-party vendors and budget control to maximize cost efficiency.
- SMO, central lab & logistics vendors
- Cold chain & sample management
- Clinical trial budgeting & cost control
- Contract management & payments
- Vendor evaluation & optimization
Cell & Gene Therapy Specialized Services
Tailored support for the unique requirements of advanced therapy medicinal products (ATMPs).
Investigator‑Initiated Trial (IIT) Support
Comprehensive assistance for IIT study design, operational management, data collection, and analysis to explore novel indications or mechanisms.
- IIT protocol design & refinement
- Project management & milestone tracking
- Data collection & management support
- Statistical analysis & results interpretation
- Manuscript writing & publication support
Cell Therapy Product Support
End-to-end operational support for cell therapy products from manufacturing to patient infusion.
- Cell manufacturing & QC assistance
- Cold chain logistics & chain of identity
- Infusion process monitoring
- Adverse event surveillance & reporting
- Long‑term follow‑up management
Gene Therapy Data Analytics
Advanced analytics for gene expression, vector integration, immunogenicity and safety signals.
- Gene expression & functional analysis
- Vector integration site analysis
- Immunogenicity data interpretation
- Biomarker discovery & analysis
- Safety signal monitoring & reporting