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