From initiation to completion, the documents required at each stage of a clinical trial must reflect both the scientific rationale and the strategic direction of the study. Leveraging the expertise of seasoned professionals with multidisciplinary backgrounds, including medical doctors, and specialists in pharmacy, nursing, biotechnology, and clinical statistics, we prepare core documents accurately and systematically, in full compliance with applicable regulations. Key documents such as the Clinical Trial Protocol, Clinical Study Report (CSR), and Informed Consent Form (ICF) play a critical role in building trust among diverse stakeholders, including regulatory authorities, researchers, internal development teams, and Institutional Review Boards (IRBs).

The Clinical Trial Protocol serves as the overall framework and direction for a study, including the trial objectives, design, methodology, subject selection criteria, and safety management plans. Based on the unique characteristics of each trial and the client’s development strategy, we prepare high-quality protocols that balance both scientific validity and operational feasibility. In addition, when developing a Protocol Synopsis, we extract the essential information and structure the key messages for each section.

The Clinical Study Report (CSR) is a document that comprehensively evaluates and interprets the results of a clinical trial, providing a scientific account of the findings based on statistical analyses, with due consideration of both safety and efficacy. Leveraging the experience of clinical statistical analysis specialists, we prepare professional reports.

The Informed Consent Form (ICF) is an essential document designed to ensure that clinical trial participants can fully understand the study and voluntarily agree to take part. The document is professionally written to meet ethical and legal standards, using terms and sentences that are understandable to the general public.