Clinical Project Services — Sailybio

IIT Clinical Research Project Services

Service Code: SLB-IIT | Category: Clinical Project Management

GCP-Compliant End-to-End Management Request Quote

Sailybio provides comprehensive Investigator-Initiated Trial (IIT) clinical research project services, from regulatory compliance approval through donor recruitment, sample collection, quality control, and final delivery. With extensive experience in UCAR-T, CAR-NK, and other cell therapy projects, we ensure professional, efficient, and compliant execution at every stage.

Service Overview

Our IIT clinical research project service supports academic investigators and biopharmaceutical sponsors in conducting clinical studies involving human biological sample collection and processing. We manage the entire project lifecycle — from institutional review board (IRB) approval and human genetic resource (HGR) administration filing, through donor recruitment and sample collection, to quality-controlled delivery of biological materials.

We have successfully operated multiple UCAR-T and CAR-NK screening and collection projects, demonstrating high recall rates for target populations and robust project management capabilities. Our team has assisted more than ten foreign-sponsored projects in passing IRB/ethics review and HGR approval at research centers, successfully initiating sample collection.

Service Scope

Regulatory compliance support — IRB/ethics committee submission, HGR administration filing
Donor recruitment & screening — multi-channel recruitment with strict eligibility criteria
Biological sample collection — peripheral blood, apheresis, bone marrow, tissue collection
Cell processing & cryopreservation — PBMC isolation, plasma separation, cell banking
Project monitoring & quality assurance — site initiation, routine monitoring, study close-out
Cold-chain logistics & sample delivery — temperature-controlled transport to designated facilities
UCAR-T / CAR-NK donor management — healthy donor screening, apheresis collection, and recall programs

Key Advantages

Multi-Project Experience

Successful UCAR-T / CAR-NK projects with strong risk early-warning capability and high target donor recall rates

Professional Team & SOPs

Comprehensive management system with standardized SOPs, independent monitoring protocols, and dedicated project managers

Regulatory Expertise

10+ foreign-sponsored projects successfully passed IRB, ethics, and HGR approval at research centers

Rich Expert Network

Extensive clinical, HGR, and GCP expert resources; strong hospital partnerships in key regions with rapid response times

Service Workflow — From Compliance to Delivery

Full-cycle quality control system with high-efficiency response at every stage

Regulatory Compliance & Approval

Prepare and submit IRB / ethics committee applications and Human Genetic Resource (HGR) administration filings. Our regulatory team coordinates with research centers to ensure timely approval and project initiation.

Protocol and informed consent document preparation
IRB / ethics committee submission and follow-up
HGR administration filing and approval tracking

Donor Recruitment & Screening

Multi-channel recruitment through stable partnerships with multiple recruitment agencies. Capable of recruiting up to 100 volunteers per day with strict eligibility screening.

Donor screening: nationality, occupation, residence, health status
Stable recall capability for target populations — high recall rates
Customized screening criteria per project requirements

Sample Collection

Collection performed at qualified, well-managed partner hospitals with professional staff and dedicated equipment, ensuring safety and stability throughout the collection process.

Peripheral blood, apheresis, bone marrow, and tissue collection
Dedicated collection team with clinical certification
On-site processing and stabilization of biological samples

Quality Control & Monitoring

Comprehensive monitoring system covering the entire project lifecycle, from initiation to close-out.

Site initiation visit → first enrollment monitoring visit → routine monitoring → site close-out monitoring → study closure
Independent monitoring team ensures protocol compliance
Real-time issue tracking and risk early-warning system

Service Delivery

Professional cold-chain logistics with full temperature monitoring, ensuring samples meet transport requirements and delivery timelines.

Cryogenic and 4–8°C cold-chain transport options
Real-time temperature tracking and documentation
Chain-of-custody documentation for all samples

Request a Custom Quote

Pricing is tailored to project scope, sample types, donor requirements, and monitoring intensity. Our project managers will design a customized service plan and provide a detailed proposal.

Start Your Project

Email: info@sailybio.com
Phone: +86 21 5550 0992
Response Time: Within 24 hours

Project Highlights

10+ foreign-sponsored projects completed

Multiple UCAR-T / CAR-NK projects delivered

100+ volunteers per day recruitment capacity

Certified hospital partnerships in key regions