Clinical Documents Preparation

我们的团队提供专业临床试验资料的准备和撰写服务。协助申办方完善临床试验所需的文件，以确保试验管理的规范化和高效性。

During the clinical trial process, participants should accurately and compliantly record the entire process according to GCP requirements. Before initiating a clinical trial, relevant materials need to be prepared and designed based on product characteristics and trial procedures.

• Investigator information: including CV, qualification certificates, GCP certificates, signature samples, and authorization forms.
• Subject information: informed consent forms, case report forms, original medical records, screening and enrollment forms, identification code tables, and completed trial subject coding directories.
• Trial product information: investigator's brochure, clinical trial instructions, material handover forms, product receipt forms, storage distribution usage and recovery records, temperature and humidity check forms, etc.
• Trial process information: meeting records and sign-in sheets for various stages, etc.