Focused on Clinical Trial Data Services, Deeply Rooted in Medical Device and FSMP Fields
LinShutong is a professional CRO service company specializing in clinical trial data management, biostatistics, and statistical programming. Headquartered in Shanghai with a nationwide service network, we are dedicated to providing high-quality clinical data solutions for global pharmaceutical companies, biotechnology companies, medical device companies, and food for special medical purposes (FSMP) enterprises.
We have deep expertise in medical device clinical trials and food for special medical purposes clinical trials, familiar with the "Good Clinical Practice for Medical Device Clinical Trials" and FSMP-related regulatory requirements. Our team is proficient in CDISC international standards and familiar with FDA, NMPA, and other regulatory agency requirements. We have successfully completed data services for hundreds of clinical trial projects, with extensive experience in diagnostic reagents, high-value consumables, medical equipment, and total nutrition formula foods.
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Full-stage data services covering Phase I-IV clinical trials, BE trials, medical device clinical trials, and FSMP clinical trials
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Proficient in CDISC standards, ensuring data submission packages meet FDA, NMPA, and other regulatory requirements
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Support for mainstream EDC systems including Medidata Rave, Oracle Clinical, and Veeva
Clinical Trial Data Services Process
Mission · Vision · Values
We uphold the principles of professionalism, integrity, and innovation, committed to becoming the most trusted partner for clinical trial data services
Our Mission
To contribute to human health through professional data services that support drug development. We are dedicated to providing our clients with the highest quality clinical trial data solutions, ensuring data quality and compliance for every research project.
Our Vision
To become a leading clinical trial data service CRO in China, building a world-class data management team, and winning the trust and recognition of global clients through excellent service quality and innovation capabilities.
Core Values
Professionalism First, Quality Priority, Customer-Centric, Integrity and Compliance, Continuous Innovation
Company History
Ten years of perseverance, from startup to growth, we have always focused on the field of clinical trial data services
Company Founded
LinShutong was established in Shanghai, with a founding team composed of data management experts with extensive industry experience, focusing on providing professional clinical trial data management services for pharmaceutical companies.
Business Expansion
Team expanded to 20 people, business expanded to biostatistics and statistical programming, established a complete clinical trial data service system, serving more than 30 clients.
Quality Management System Established
Established a comprehensive quality management system, obtained ISO 9001 quality management system certification, project delivery quality highly recognized by clients, with over 200 projects completed.
International Development
Service scope expanded to international markets, established partnerships with multiple multinational pharmaceutical companies, team size reached 40 people, annual project delivery exceeded 100.
Continuous Innovation
Introduced AI-assisted data verification technology to improve data management efficiency. Team size exceeded 50 people, cumulative service projects exceeded 500, becoming an industry-leading clinical trial data service provider.
Company Structure
Scientific and rational organizational structure ensuring efficient project management and quality service delivery
Data Management Dept
Responsible for full-process clinical trial data management services, including CRF design, database construction, data cleaning, etc.
Biostatistics Dept
Provides statistical consulting, protocol design, statistical analysis plan development, and statistical report writing services
Statistical Programming Dept
Responsible for SDTM/ADaM dataset production, TLF programming, and Define.xml document preparation
Data Science Dept
Focuses on data technology innovation, including AI-assisted verification, automation tool development, etc.
Why Choose LinShutong
With years of industry experience and a professional team, we provide excellent clinical trial data services for our clients, helping drug development projects proceed smoothly.
Learn More About ServicesProfessional Team
Elite team composed of senior data managers, biostatisticians, and statistical programmers, with an average of over 8 years of industry experience
International Standards
Strictly follows international standards such as CDISC and ICH-GCP, ensuring data meets FDA, NMPA, and other regulatory requirements
Quality Assurance
Comprehensive quality management system with multi-level review mechanisms, project delivery first-time pass rate up to 98%
Efficient Delivery
Mature project management processes, standardized operating procedures, average project cycle shortened by 20%
Professional Qualifications & Certifications
Strict quality management system ensuring services meet international standards and regulatory requirements
ISO 9001 Certified
ISO 9001 quality management system certification obtained, with established quality management processes and standard operating procedures
ISO 27001 Certified
ISO 27001 information security management system certification obtained, ensuring confidentiality and security of client data
CDISC Certified
Team members hold CDISC certifications, proficient in SDTM, ADaM, Define.xml, and other standards
SAS Certified
Statistical programming team holds SAS Base and Advanced certifications, ensuring programming quality and efficiency
Professional Training
Regular training on regulations such as ICH-GCP, 21 CFR Part 11, maintaining up-to-date professional knowledge
Industry Associations
Member of China Pharmaceutical Quality Management Association, China Clinical Trial Data Management Association, and other industry associations
Therapeutic Areas Covered
We have extensive project experience in multiple therapeutic areas, providing professional data services for our clients