Clinical Research Services
CGT-Specific Clinical Research
BojiMed boasts distinct advantages in CGT services. Backed by experience from 50+ projects and a team of CDE experts, we have built an end-to-end "one-stop" service system covering the entire lifecycle from IND to NDA, accelerating the market launch of cell and gene therapy innovations.
CGT-Specific Clinical Research
INTRODUCTION
Boji Medical Technology Co., Ltd.(BOJIMED) offers significant advantages in cell and gene therapy (CGT) services. The company brings together a team of multiple review experts with CDE backgrounds, who provide professional guidance on declaration strategy, clinical medical planning, and other aspects.
To better achieve precise services for CGT projects, BOJIMED has established a specialized subsidiary dedicated to the CGT field, ensuring the smooth and reliable project execution. Leveraging experience from over 50 CGT projects, BOJIMED has built a comprehensive, full-life cycle service system that spans IND declaration, clinical research, and NDA filings—offering CGT companies truly integrated, on-demand "one-stop" solutions.
To better achieve precise services for CGT projects, BOJIMED has established a specialized subsidiary dedicated to the CGT field, ensuring the smooth and reliable project execution. Leveraging experience from over 50 CGT projects, BOJIMED has built a comprehensive, full-life cycle service system that spans IND declaration, clinical research, and NDA filings—offering CGT companies truly integrated, on-demand "one-stop" solutions.
OUR ADVANTAGES
Full-process Guidance by Authoritative Experts
- Dr. Wan Zhihong (Chief Scientist): With rich experience in basic research, clinical practice, and clinical review of cell and gene therapy products, especially providing multi-dimensional advice in fields such as iPSC, CAR-T, and TIL.
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Dr. Li Xinxu (Chief Scientist of Biostatistics): With extensive experience in statistical professional review of new drug clinical trials for indications such as cardiovascular diseases, hematological tumors, respiration and allergy, mental and neurological diseases, radiology, and imaging, providing strong support for statistics of cell therapy products.
Rich Project Experience
- BOJIMED has numerous successful cases in cell therapy projects, spanning areassuch as stem cells, immune cells (e.g., CAR-T, TCR-T), gene therapy, and oncolytic viruses.
- Over 50 cell therapy projects , including IND declarations, IIT studies, Phase I/II clinical trials, covering diverse indications inoncology, immunology, digestion, respiration, and cardiovascular and cerebrovascular diseases.
Standardized Quality Control System
Robust standard operating procedures (SOPs) and a comprehensive quality assurance and control system ensure all projects are executed with consistency, quality, and regulatory compliance. We have achieved a 100% inspection pass rate from the National Medical Products Administration and provincial bureaus, highlighting full compliance with the national standards.Reasonable Pricing and Confidentiality Principles.
Reasonable Pricing and Confidentiality Principles
- Optimize clinical trial design to reduce customer costs while maximizing efficiency, aiming for mutual benefit, win-win outcomes.
- Enforce rigorous confidentiality protocols to fully safeguard client’s intellectual property and trade secrets, ensuring comprehensive protection of sensitive information.
SERVICE CONTENT
Preclinical Project Consulting
- •Project development planning
- •Pharmaceutical research
- •Pharmacodynamic research
- •Pharmacokinetic research
- •Safety evaluation tests
IND Registration and Declaration
- •Preparation and application of
- Pre-IND meeting materials
- •Compilation and review of declaration documents (covering modules such as clinical trial plans, protocols, risk control plans, etc.)
- •Response to CDE technical reviews and supplementary materials
Clinical Operation
- •Screening of research centers, project approval, and pre-approval of ethics
- •Rapid initiation and monitoring
- services for trial centers
- •Subject recruitment and compliance management
- •Data management and statistical analysis
- •Pharmacovigilance management
- •Clinical trial site management services
Filed Clinical Development
- •Support the declaration of cell therapy as medical technologies, facilitating registration in the National Health Commission's stem cell research filing system and managing the ethical review process with Provincial Health Commission and medical ethics committees.