Site feasibility survey
Big data query/Institution information survey/Investigator information survey
Patient pool and enrollment progress assessment/Site evaluation report
Project initiation, ethics committee, and human genetic resources administration submission support
Assistance in site initiation, ethics information collection, and document preparation and revision
Pre-review of initiation and ethics documentation
Support for initiation meetings, institutional review meetings, and ethics committee meetings
Assistance in human genetic resources filing and related procedures
Contract negotiation and site initiation support
Collection of cost details and contract drafting, negotiation, and execution
Receipt and management of investigational products and supplies
Collection and archiving of site qualification documents
Site initiation visit support
Subject screening and recruitment
Precise subject screening in accordance with protocol requirements
Extensive investigator resource pool to efficiently accelerate enrollment progress, particularly in oncology research
Collaboration with relevant organizations and enterprises to provide multi-channel recruitment approaches, especially for rare diseases and chronic disease research
Trial data entry and review
Tracking the entire patient treatment and follow-up process in accordance with ICH-GCP principles and clinical trial protocol requirements, effectively controlling dropout rates
Subject management
Assisting study site staff in efficiently and accurately organizing and completing source documentation
Efficient data entry and query resolution according to trial and client requirements, ensuring timeliness of data entry
Site management and maintenance
Daily communication and liaison with IRB/ethics committees
Study document management
Investigational product and supplies management
Project financial management
Monitoring, audit, and inspection support
Adverse event and serious adverse event reporting
AE/SAE progress tracking
Filing and archiving of safety documentation
Assistance in AE/SAE information collection, documentation, and reporting
Query resolution assistance
Close communication with investigators, providing efficient and high-quality responses to queries
Two-way communication and feedback to ensure the quality of query resolution
Site close-out
Institutional quality control support
Ethics committee final review meeting
Financial settlement
Audit/inspection support and corrective actions
Submission of sub-center summary reports
Document archiving
On-site inspection support
Pre-audit/inspection preparation
Audit/inspection support and corrective actions
As a local force rooted in South China, our core strength lies in our deep presence across cities at all levels in Guangdong Province, having established strong ties and deep trust with medical institutions, GCP sites, and core clinical departments at all levels within the province. This unique advantage gives us strong grassroots execution capabilities and resource allocation authority in site evaluation, rapid initiation, challenging recruitment, and daily communication for projects in Guangdong.
We have successfully passed vendor audits conducted by multiple well-known domestic pharmaceutical companies such as Hengrui and Haosen, and have established long-term, stable strategic partnerships with many leading pharmaceutical enterprises.
We place great emphasis on project quality and continuity, providing sufficient backup personnel for each partner institution and project to ensure zero gaps in project execution.
With a professional and efficient service system and a comprehensive operational network, Guangzhou Evidence Based Medicine is committed to providing tailored one-stop traditional Chinese medicine research and development full industry chain service solutions for every customer, promoting traditional Chinese medicine to the world and safeguarding the health of more people.
