digital-one-stop Clinical Research Service
(1)Recruitment of clinical trial subjects
The online subject recruitment platform - YooTrial Recruit is the first non-profit subject recruitment service platform in Central and South China, and also one of the recruitment platforms with a wide range of influence and the most comprehensive services. Its business covers recruitment of healthy subjects for Phase I/BE clinical studies, recruitment of patients for Phase I-IV clinical studies.
(2)Duplicate checking and authentication of subjects
The self-developed YooTrial Auth can intelligently query and identify subject information. Meanwhile, a subject database is jointly established with Taimei Technology and Guangdong-Hong Kong-Macao Alliance to open up the functions of authentication and mutual querying. At present, it has covered 200+ domestic institutions and 200,000+ subjects, effectively meeting the needs of subject screening in the clinical trial centers and ensuring the data authenticity.
Changsha Linkmeds Co., Ltd., a subsidiary of Duxact, is committed to providing professional and efficient clinical trial project implementation plans for clinical institutions, clinical research physicians and medical device R&D companies, and assisting research institutions and investigators in managing clinical trial projects, including feasibility studies, quick start of trials, on-site implementation, quality control, and full-process project management.
Biological sample analysis and testing
The Analysis and Testing Center is committed to building an international and standardized analysis and testing platform for in vivo drug analysis. A quality management system has been established and operated in strict accordance with CNAS-CL01: 2019, and passed the ISO/IEC 17025 laboratory accreditation. More than 260 biological analysis and testing methods are developed, and the average incurred sample reanalysis (ISR) pass rate of completed projects is ≥ 99% (industry standard is ≥ 67%).
Medical affairs service
The Medical Affairs Development Center provides drug clinical trial protocol design and preparation, drug clinical trial summary report preparation and review, technical support for clinical pharmacokinetics and genetic pharmacokinetics, etc.
Clinical data management
Provide data management services that support the entire clinical research process as required by ICH, GCP and regulatory authorities, follow ALCOA + data quality principles, and adopt industry-leading clinical data management systems and tools to ensure that clinical research data is standardized, authentic, and reliable while achieving the best cost-effectiveness.
Provide customers with efficient and high-quality biostatistical analysis services throughout the clinical research and development process from clinical trial statistical design, implementation to result reporting. In addition, biostatisticians work closely with data administrators and medical personnel to ensure the correct collection of project data, thus avoiding risks.
Cooperate with the world's top-level pharmacovigilance team to provide services throughout the entire development process, from the investigational new drug application (IND) to post-marketing pharmacovigilance. The company can provide high-quality and efficient medical safety monitoring solutions for various enterprises.
Consultation concerning GCP filing
Relying on its own advantages, the company has integrated a complete set of institution filing system documents and counseling mechanism to provide medical institutions with full-process medical device/drug clinical trial filing and quality consulting services.
Provide professional drug registration related services, and maintain effective two-way communication with customers and government regulatory authorities from multiple levels and aspects of procedural requirements, regulatory requirements, and technical compliance, etc. to ensure the rapid progress of project.