Clinical development strategy, protocol development, sample size estimation, statistical analysis plan, response to MFDS/IRB comments, quality management, or any topics you want to discuss about can be our common topics to be solved together.
IB, Protocol, ICF, CRF, CSR
SAP, statistical analysis, CTD Module 2&5
Response letter to regulatory body/IRB
Manuscript editing, abstract or poster preparation, Independent statistical analysis
Korean, English, Polish
Trainings customized for burgeoning researchers, CRAs, CRCs, project managers, and medical writers on the various topics: literature search, manuscript preparation, study design, practical issues confronted in clinical trials, etc.
Statistical services will be delivered by cooperation with the partner company SciencePro.