In order to provide high-quality document preparation services, we use our own protocol template, which satisfies both the MFDS and ICH requirements, and our ICH E3-compliant CSR template. We also have our QC staff participate in the process of preparing protocols and CSRs to make sure of the quality of those documents.
Our medical writers with a Masters or Ph.D. degree and clinical research experiences in various therapeutic areas develop protocols and CSRs. Our statisticians provide statistical support in the determination of sample size, description of statistical methods, etc. Also, our Clinical Operation Team and Data Management Team systemically coordinate with the medical writers in the protocol/CSR development process.
Use of high standards in selecting study design and statistical methods helps us to deliver better document outputs.