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About SDM
Solutions
One-Stop Service
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Data Management & Statistics
Pharmacovigilance
Laboratory
Audits
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Insights
Why SDM
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SDM Is Your Trusted Partner for Clinical Development

1000
+
CRO Team Members
13
Office Locations
80
+
Major Cities with Resident Staff
300
+
Clients Served Last 3 Years
600
+
Long-term Partners
1000
+
Projects Successfully Completed

One-Stop Clinical Development Solutions

SDM Bioservices offers comprehensive support for product development strategy, regulatory registration, clinical operations and site management, laboratory tests and statistical services. Our highly specialized, international team is dedicated to helping your project succeed both in China and global markets. MORE >>

SERVICES
Medical Affairs
  • Medical strategy
  • Medical writing
  • Medical monitoring
  • Medical translation
Registration Affairs
  • Regulatory strategy
  • Technical writing
  • Submissions and maintenance
  • Ad hoc consulting
Project Management and Operations
  • Project planning
  • Project implementation
  • Project monitoring
  • Meeting organization
Laboratory
  • Vaccine platform
  • Antibodies platform
  • CGT platform
  • Small molecule platform
Data Management and Statistical Analysis
  • Data management & statistical planning
  • Database design & development
  • Data verification & quality control
  • Statistical analysis
Pharmacovigilance
  • Safety information management
  • Safety monitoring & risk management
  • Post-market safety information management
  • PV system setup and improvement
Other Services
  • Phase I unit construction
  • HGRAC interaction & submissions
  • Third-party audit
  • Specialized clinical trial solutions

Comprehensive Expertise Across Therapeutic Areas

With extensive expertise across therapeutics, vaccines, medical aesthetics and medical devices, we deliver unique insights and client-tailored solutions to meet your needs.

BUSINESS

Therapeutics

• Non-Oncology: Endocrinology & metabolism, infection, respiratory, immunology, neurology, ENT, ophthalmology, gynecology, adults & pediatric, etc.

• Oncology: Hematologic malignancies (B-cell, T-cell, AML, etc.), solid tumors (urologic cancers, gynecologic cancers, breast cancer, lung cancer, etc.)

• Innovative Therapies: Radiopharmaceuticals (therapeutic, diagnostic), ADC, mRNA, CGT, therapeutic vaccines, etc.

Vaccination

• Viral Vaccines: HPV, Shingles, RSV, Norovirus, Rotavirus, Rabies, Influenza, Meningitis, etc.

• Bacterial Vaccines: Pneumococcal, Conjugate, DTP (Diphtheria, Tetanus, Pertussis) combination, etc.

Medical Aesthetics

Specialized in materials such as sodium hyaluronate, collagen, regenerative substances and botulinum toxin, with extensive clinical research and regulatory experience in contouring and appearance improvement in treatment areas including forehead, temples, nose, jawline, hands and neck.

Medical Devices

Specializing in ophthalmology, cardiology, neurology, vascular surgery, orthopedics, in vitro diagnostics and other fields ranging from Class I, Class II and Class III devices.

Therapeutics

Vaccination

Medical Aesthetics

Medical Devices

News

NEWS
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2025-04-23
SDM Bioservices supports Kygent in securing FDA Orphan Drug Designation for KY-001
KY-001 is an oral small-molecule inhibitor targeting the YAP/TAZ-TEAD interaction in the Hippo pathway with a proposed indication for advanced solid tumors driven by Hippo dysregulation.
MORE >>
2025-04-17
SDM Sharing | Transformative Frameworks in Data Management
Clinical Database Design: Balancing Standardization and Innovation
MORE >>
2025-04-10
SDM Sharing | Pre-IND Meeting Preparation Guidelines (China)
this article outlines essential documentation preparation and strategic considerations for conducting pre-IND communication meetings with CDE, ensuring effective regulatory alignment and adequate guidance.
MORE >>
2025-03-28
VIF 2025 REVIEW | Dr Mo Zhaojun on Vaccine Clinical Trials: Practical Insights to Avoid Pitfalls
SDM Vaccine Experts Share Roadmap to Avoid Clinical Trial Pitfalls.
MORE >>
2025-03-14
Interview | Dr. Shen Liping: We are not only supporters of vaccine development but also drivers of industry innovation
Listen to Dr. Liping Shen: Innovating Vaccine Bioanalysis for Change
MORE >>
2025-02-25
SDM Bioservices Supports Meiji in Successful FDA Clinical Trial Application for MJC-001, the World’s First Oral Paclitaxel Softgel Capsule
Meiji has advanced its oral paclitaxel softgel capsule, MJC-001, to clinical trial stage. With support from SDM Bioservices, Meiji received FDA clearance for its Investigational New Drug (IND) application, positioning it among the leading developers of oral paclitaxel formulations.
MORE >>
2025-02-10
SDM: Bioanalytical Laboratory, a New Engine for One-Stop CRO Services
The laboratories operated by SDM in the North and South have their own specialties and technical advantages. Among them, Beijing Shouyan, with several P2 and P2+ laboratories and complete PCR testing facilities, is one of the few testing organizations in China focusing on bioanalysis of vaccines and traditional Chinese medicines; Hangzhou Amador focuses on XDC, macromolecules, and CGT, etc., and provides one-stop bioanalytical services for ADC drugs, which is a technological leader in the industry.
MORE >>
2025-01-23
SDM Bioservices Supports Novatim Immune Therapeutics in Successful FDA and NMPA Clinical Trial Applications for KY-0301, the World’s First Nanobody-Based Bispecific ADC
KY-0301 is the world's first nano-dual-anti-ADC developed by Novatim based on its own innovative nano-dual-anti-ADC platform “TPEBEN”.
MORE >>
2025-01-21
Good News | SDM's laboratory, Beijing Shouyan Lab has passed the NGSP certification
Beijing Shouyan Lab is certified by NGSP in the United States.
MORE >>
2025-01-09
SDM helps Gan&Lee Pharmaceuticals GZR18-T2DM-302 Injection Hypoglycemia Phase III Clinical Trial
Provide diverse and better treatment options for patients worldwide.
MORE >>
2025-01-01
Step into SDM's 20's with highlight marks | 2024 Year in Review
At the intersection of the end of the year, we sincerely invite you to join us in focusing on the shining points of the year, and to look back together and cherish the bright moments that have illuminated our way forward in the past year.
MORE >>
2024-10-25
Dr. Yuwen, CBO and SVP of SDM, was invited to attend the DIA International Biomedical Industry Innovation Beijing Forum to discuss global clinical development
On October 24-25 2024, Dr. Yuwen, CBO and SVP of SDM Bioservices, was invited to attend the 2024 International Biomedical Industry Innovation Beijing Forum co-sponsored by DIA and Beijing Advanced Medical Equipment Industry Innovation Alliance. The forum brings together representatives of global regulators, leading experts in biomedicine, industry leaders and academics to discuss the latest trends and industry innovations in global drug development.
MORE >>
2024-10-21
SDM shines AMWC China 2024
AMWC China 2024 World Congress on Aesthetics and Anti-Aging was successfully carried out in Chengdu on October 18-20, 2024, with medical and aesthetic experts, scholars, and industry practitioners from all over the world participating and presenting their latest achievements.
MORE >>
2024-09-12
SDM Bioservices reached a strategic cooperation with JP Medical Consultants Limited to accelerate the internationalization process and escort the clinical trials of Chinese biopharmacetical enterprises in Australia
On July 24, SDM Bioserices and Australia JP Medical Consulting Pty Ltd (hereinafter referred to as "JP Medical Consulting") announced a strategic cooperation. The cooperation aims to make full use of the clinical resources and professional advantages of the two sides in the field of medicine in China and Australia, promote the internationalization of clinical trials and new drug research and development, and provide one-stop services for Chinese biopharmaceutical enterprises in Australian clinical trials.
MORE >>
2024-08-02
Liu Xueliang, deputy secretary of the District Party Committee and district governor, led a team to visit key enterprises of Daxing biomedical industry base
August 1, China, Beijing, Liu Xueliang, deputy secretary of the District Party Committee and district governor, led a team to visit key enterprises of Daxing biomedical Industry Base to investigate the development and construction of pharmaceutical research and development service platform enterprises.
MORE >>
2024-07-18
SDM and Tonghua Dongbao successfully completed the "Diabetes Professional CRA Series Course"
On the way to further explore and promote the professional development of medical clinical trials, SDM and Tonghua Dongbao jointly successfully held a nine-month "Diabetes Professional CRA Series course".
MORE >>
2024-07-13
Learning is a never-ending process | MSSO face-to-face training is a complete success
On July 11-12, 2024, MedDRA MSSO successfully held the fourth offline face-to-face training of 2024 at the Shenyang office of SDM. As the organizer of this event, SM gathered together with more than 40 experts from various fields such as CRO, pharmaceutical companies and partners, including medical coders, data management and statistics, drug safety/pharmacovigilance, medical writers and other modules.
MORE >>
2024-07-04
SDM Group and Dr. Yaning Wang of Ruiningkang Bio-have reached a strategic cooperation to jointly develop a new era in the field of medicine
On July 3, 2024, SDM Bioservices and Shanghai Ruiningkang Bio-Pharmaceutical Technology Development Co., LTD. (" Ruiningkang Bio ") reached a strategic cooperation to work together to help innovative drugs in the quantitative pharmacology, dose exploration level, and promote more innovative drugs with global competitiveness to the market.
MORE >>
2023-11-23
Shanghai SDM helped Kangle Guard Phase III clinical trial of nine-valent HPV vaccine officially start enrollment vaccination in Indonesia
On November 21, 2023, Beijing Kangle Guard Biotechnology Co., Ltd. is affiliated with Muhammadiyah University Malang, Indonesia (at) to start the "restructuring nine price 6/11/16/18/31/33/45/52/58) human papilloma virus (HPV) vaccine (e. coli) phase III clinical trials into the group of vaccination. As a CRO focused on vaccine clinical trials, Shanghai SDM undertook the phase III clinical study of the vaccine project in Indonesia, responsible for project management, data management, biostatistical analysis, pharmacovigilance and other important work of the project.
MORE >>

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