01. Clinical Development Strategy and Protocol Design
Humphries's clinical team has extensive experience in clinical design, development, and execution. We can provide top-level design and strategic support tailored to the characteristics of your product, specific clinical needs in the therapeutic area, and your regulatory or business objectives. Strategic services we offer include but are not limited to:
Target Product Profile (TPP)
General investigator plan
Design and optimization of Phase I-IV clinical trial protocols
Analysis of clinical deficiencies under specific regulatory targets (Pre-IND/IND/EOP2/NDA/BLA, etc.)
Feasibility assessment for special designations and pathways (ODD/RPDD/FTD/BTD/RMAT)
Regulatory agency meeting support
Project evaluation
Due diligence
02. Medical Writing
Medical writing is crucial throughout the entire drug clinical development process for the successful implementation of clinical trials and obtaining regulatory approval. Humphries's medical writing team provides comprehensive, high-quality, and compliant medical writing services. Writing services we offer include but are not limited to:
Clinical trial protocols
Informed consent forms
Investigator's brochure
Clinical overviews and clinical summaries (CTD Modules 2.5 and 2.7)
Clinical study reports (CSR)
FDA Annual Reports/Developmental Safety Update Reports (Annual Report/DSUR)
Briefing documents for milestone meetings (INTERACT Meeting/Pre-IND/EOP1/EOP2/Pre-NDA/BLA, etc.)
Materials for special designations and pathways
03. Assistance in Clinical Trial Execution
Humphries can provide support during your clinical execution stage, including but not limited to:
PI and KOL screening
Clinical CRO selection
Clinical trial monitoring
GCP inspection