Service Introduction

Data Management and Statistics

Data Management and Statistics

Provide comprehensive, high-quality, high-standard and high-efficiency data management statistical services for statistics in the medical field

• CRF/database design and building
• Data management
• Statistical analysis

RA Service

RA Service

Provide strategy consultancy on drug development and registration, Sino-US of Investigational New Drug Application (IND), New Drug Application (NDA) document preparation and application service.

• Generation and guidance of registration policy
• Pre-review and feasibility assessment
• Guidance to answer questions
• CDE communication application and guidance
• IND / NDA complete application
• On-site review and standard review inspection

Third Party Audit

Third Party Audit

Provide professional third-party audit services.

• BE、PK、Phase I trial audit
• Phase II-IV clinical trial site audit
• Trial master files (TMF) audit
• Set up clinical trial SOP
• Research institution quality management system audit
• Data management audit
• Statistical analysis audit
• Clinical study report (CSR) audit
• Checking before clinical trial submitting NMPA
• Centralab audit

SMO Service

SMO Service

Provide direct assistance and Study Coordinator service for researchers; perform all duties conferred by researchers. Devote to providing professional services related to clinical trials to assist researchers and research institutions to undertake nonmedical judgment clerical work in clinical trials, improve the quality and progress of clinical trials, and promote the standardized process of clinical trials. 

• CRC Service

• Feasibility Study of Research Center
• Communication with Ethics Committee and Research Institute
• Subject recruitment and management
• Data audit and quality control

Medical Affairs & Strategy

Medical Affairs & Strategy

Provide professional medical services, including product medical strategy formulation, medical project design, post-marketing clinical study design, etc. Also provide design for market access and development of pharmacoeconomics research.

• Product development strategy consultation

• Clinical study report writing and review

• Standardized monitoring of curative effect index evaluation

• Evaluation consistency audit

• Original record

• Medical logic review

Clinical trial R&D

Clinical trial R&D

Clinical trial Phase I-III, phase IV and post-market re-evaluation trial, including consultation services, project management, clinical monitoring, quality control and training, etc. Studies led by researchers, bioequivalence trial.

• Clinical trial feasibility assessment
• risk identification management
• Clinical trial training
• IEC/IRB plan submission  
• Human Genetic Resource Administration of China(HGRAC) application
• Serious adverse event(SAE) management
• Answer questions