(I) Service Content

Providing full-lifecycle management from project initiation, subject recruitment, and clinical monitoring to project close-out.

(II) Service Advantages

1. Focus on advantaged therapeutic areas with deep resource reserves

   we have accumulated extensive project experience in TCM advantaged disease areas, particularly in core therapeutic fields such as respiratory medicine, gynecology, orthopedics, and oncology, and have established in-depth KOL/PI networks and clinical center collaboration matrices, with a profound understanding of the clinical evaluation logic and recruitment characteristics of such diseases.

2. Commitment to a "full-process partnership" service model

   breaking the traditional mechanical client-vendor boundaries, we closely integrate our project teams with sponsors. From early project stages to close-out, we provide highly responsive and transparent proactive collaboration, resonating with clients at every step, sharing risks, and jointly solving problems.

3. Adherence to the "Quality by Design (QbD)" principle

   we do not push forward blindly, but rather integrate product characteristics with clinical pain points and intervene early in the project top-level design phase. By front-loading recruitment funnel planning, operational risk control, and data standards, we prevent execution deviations at the source, ensuring high-quality and efficient project delivery.

(I) Service Content

Providing compliant and rigorous prospective and retrospective clinical operations services based on multi-scenario real-world data (RWD).

(II) Service Advantages

1. Multi-scenario application and purpose-oriented strategy

   we are able to provide tailored operational implementation plans for different research objectives, covering diverse scenarios such as mining potential new indications for products, retrospective evaluation of human experience data for TCM, and post-marketing safety assessment, ensuring that data outputs meet the corresponding levels of clinical evidence.

2. Compliant multi-source data collection and cross-departmental collaboration

   we are proficient in the access pathways and governance standards for real-world data. With hands-on experience in deep collaboration with hospital information departments and clinical departments, we are able to effectively overcome operational barriers such as unstructured data source tracing and EHR system integration, ensuring the completeness and compliance of underlying data.

3. Experience in decentralized clinical trial (DCT) implementation

   we have the capability to design operational systems that extend clinical research from traditional hospital settings to out-of-hospital scenarios. In out-of-hospital prospective projects such as research-based pharmacies, we are able to establish rigorous participant recruitment, follow-up tracking, and data collection mechanisms, effectively broadening the dimensions of evidence collection while controlling data bias.

(I) Service Content

Providing comprehensive operational services for research projects for clinical discipline leaders and core experts, assisting in full-chain management including project progress promotion, quality control, participant management, data management, and statistical analysis. 

(II) Service Advantages

1. Extensive experience in chronic disease and cohort studies

   we have successfully undertaken multiple research projects on the "four major chronic diseases" and large-scale clinical cohort repositories, with a deep understanding of the disease patterns and core operational characteristics of such large-scale, long-cycle research initiatives. 

2. Refined long-term follow-up and fund management

   closely addressing the practical pain points of clinical expert-initiated projects, we have mature experience in long-term subject follow-up management and compliance maintenance (effectively controlling dropout rates); at the same time, we are proficient in the financial management requirements of research projects, assisting experts in compliant and refined budget control and coordinated fund utilization.

3. Cost-effective delivery of research quality

   leveraging a mature professional CRO operational system and resource mobilization capabilities, we provide customized operational plans for expert teams. While ensuring the research quality, scientific rigor, and data robustness of the projects, we achieve efficient resource allocation and highly cost-effective service delivery.

(I) Service Content

Providing retrospective study data governance, human experience evidence evaluation, and standardized clinical operations services for human experience research.

(II) Service Advantages

1. Precise understanding of the "three-combination" review system and policy orientation

   we have a deep understanding of the national registration and review logic for new TCM drugs based on the "TCM theory, human experience, and clinical trials" three-combination framework. Our core team has previously served as review experts leading the selection of the "Lingnan Famous Prescriptions" in Guangdong Province, with a precise grasp of the druggability assessment of TCM preparations in medical institutions and the evaluation standards of regulatory authorities for human experience evidence.

2. Full lifecycle pathway from hospital preparations to new drug conversion

   we have successfully conducted multiple human experience research projects on TCM preparations in medical institutions, with extensive operational experience. We are able to work backwards from the endpoint of new drug IND/NDA applications, conducting rigorous data governance and evidence-based evaluation on unstructured clinical diagnosis and treatment historical records, facilitating the scientific transition of TCM preparation assets in medical institutions toward new drug development.

(I) Service Content

Assisting sponsors in establishing a systematic quality control system that complies with domestic regulatory requirements and is applicable to the target organization, providing core services including system status assessment, development and review of standard operating procedures (SOPs).

(II) Service Advantages

1. Cutting-edge international awareness of system frameworks

   we possess comprehensive and in-depth knowledge of the core elements and implementation frameworks for cQMS construction from authoritative industry organizations such as TransCelerate, ensuring that the design of the quality management system is forward-looking, scientific, and compliant with high-standard regulatory rigor.

2. Customized adaptation through a "partnership co-construction" approach

   we uphold a deep partnership relationship, avoiding the rigid application of templated processes. We precisely analyze the sponsor's current organizational structure, resource allocation, and pipeline characteristics, assisting in the development of a cQMS that is highly tailored to the organization, while maintaining the quality bottom line of clinical research and taking into account the company's actual operational efficiency.

3. Full-chain system empowerment and implementation guarantee

   we provide a closed-loop service from early system baseline assessment and gap analysis, to the development of core SOPs, professional review, and process optimization.