A case of streamlining the new drug development application process through document sharing!
We would like to introduce a case study of the "Agatha application document" implemented by Japan Medical Physics Co., Ltd., a company with a long history in the field of nuclear medicine. The company was previously creating and managing CTDs on a file server, but issues arose regarding security and the difficulty in determining whether the approved electronic documents were being used correctly in the eCTD compilation. After implementation, they were able to create CTDs while ensuring authenticity, readability, and preservation in accordance with the ER/ES guidelines. 【Key Points of Adoption】 - The entire process of document creation, review, and approval can be conducted within the system, making it clear which version has been approved. - Ability to create PDFs compatible with eCTD format. - It is a cloud service and is more cost-effective than other services. *For more details, please download the PDF or feel free to contact us.
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Our company provides a cloud service for creating, sharing, and storing documents related to clinical trials and clinical research on a project basis for medical institutions, pharmaceutical companies, medical device companies, CROs, SMOs, clinical testing companies, and more. In addition to offering systems specialized for the medical and life sciences industries, we provide comprehensive support from implementation to operation by staff with expertise in the medical field. Please feel free to contact us if you have any inquiries.