Drug application-related document writing
- Clinical Study Reports (CSR): Clinical studies
- Common Technical Document (CTD): Non-clinical and clinical studies
- Queries and responses
- Others (adverse event narratives, protocols, review of ICF etc.）
- Review (pathology, treatment, clinical results)
- Clinical trial (RCT, observational research, case reports, retro research, PMS)
- Non-clinical (toxicity, pharmacokinetics, pharmacology)
- Survey (questionnaire, web survey)
We support the entire process of publication which includes searching of submission guideline for target journals, drafting outline, English proofreading, publishing support, and review.
- Check the consistency of various English or Japanese documents
- Check the validity check of various English or Japanese documents
- Check the format
Project management system
|Function||Roles and Responsibility|
|Receipt and delivery of related materials and deliverables, point-of-contact for delivery process.|
Appoint person in charge for each task.
Management of work in progress.
（Writer and Editor）
|Drafting and editing the documents.|
|QC Manager||Check the completeness of quality inspection conducted by QC check (confirm the points checked, any questions or remarks). |
Other quality inspection related works.
|QC Check||Quality inspection work of draft documents prepared by the writers. |
Check the following based on the check list: any content and instructions mismatch, overall consistency.
|Business Process Check||Check whether the work is performed according to the previously agreed procedures (operation manual, work instructions etc.).|
- Pharmaceutical company： more than 30 companies
- CRO：8 companies
- Academia：4 universities