Project Management
HMC supports clinical study sponsors with study plans, coordination and progress reporting. Project responsibilities and documentation are aligned with the study protocol and applicable good clinical practice (GCP) requirements.
Clinical Operation
HMC supports clinical study sponsors with site start-up, monitoring and study-document coordination under applicable good clinical practice (GCP) requirements. Work includes trial master file (TMF) and informed consent form (ICF) documentation where specified.
Data Management
HMC supports clinical study sponsors with data management plans, case report forms (CRFs), data review and database-lock preparation. Work follows the study protocol and applicable data standards.
Biostatics
HMC supports study teams with sample-size planning, statistical analysis plans and reporting. For diagnostic studies, analysis may address sensitivity and specificity against the study protocol and intended submission requirements.
Quality Assurance
HMC supports clinical study teams with process assessments, audit planning and documentation of findings. The review scope follows the study requirements and applicable good clinical practice (GCP) standards.
Original source: HMC service overview ↗
