Study Design & Protocol Development
A well-written clinical study protocol (CSP) not only describes how a clinical trial will be conducted but ensures safety of the study subjects, integrity of the data collected and communicates the use of investigational product to study-site personnel in a simple and logical manner.
Our medical writers together with therapeutic area experts, regulatory consultants, statistician, data manager etc. can prepare study protocols or protocol amendments in line with their intended purpose and in compliance with relevant national and international regulatory requirements. Our medical writer can also prepare other study documents, including but not limited to clinical study reports, case report forms, investigator’s brochure, questionnaires etc.