Medical Services

Drawing on multi-segment project experience and extensive review cases, the team provides custom medical solutions for IIT, registrational trials, Decree No.818-related biomedical tech translation and real-world studies, balancing scientific rigor, subject safety and R&D efficiency while ensuring regulatory-compliant clinical research.

Core Services

• Clinical Development Plan (CDP) drafting

• IIT / POC trial protocol design & writing

• Biomedical innovative technology trial protocol design (Decree 818)

• Phase I/II/III registration trial protocol design & writing

• Phase IV / RWS / PMS trial protocol drafting

• Investigator brochure, informed consent and other medical document preparation

• Clinical study report drafting

• Full-cycle medical monitoring for Phase I–III trials

• Medical literature translation & collation

• iDMC / CEC specialized medical support

Core Advantages

• Full-lifecycle end-to-end medical coverage

• Scientific, executable trial design

• Senior multi-disciplinary medical experts

• Dynamic full-cycle medical risk control

• Cross-department integrated collaboration

Typical Service Scenarios

• Early exploratory R&D: POC & IIT medical support, risk prediction to mitigate late-stage trial risks

• Innovative drug registration trials: Full Phase I–III protocol design, medical monitoring & report writing for IND/NDA filings

• Biomedical technology transformation trials (Decree 818): End-to-end medical services for record-filing & conversion applications

• Generic BE consistency evaluation: BE medical dossier optimization & compliance audit to support generic approval

• Post-launch expansion studies: Phase IV & real-world research protocol drafting to enable indication expansion & academic promotion

• High-level academic review: iDMC & CEC technical support for complex global multi-center trials

Service Workflow

• Project alignment & clinical development strategy formulation

• Trial protocol, IB, ICF and CDP drafting, cross-team review & optimization

• Full-cycle medical monitoring post-trial initiation: protocol adherence audit, subject safety management, clinical issue resolution

• Real-time literature update, trial scientific & safety reassessment, dynamic protocol adjustment for review response

• Final clinical study report compilation & archiving, long-term post-market medical & review query support