Process to Contract Research
Please contact us with your questions or requests. We are able to accommodate and provide services world-wide.
- Drug Development Solutions
- Phone number +81-3-3271-5634
On investigating information for the preparation of study plan, we might ask client to disclose the data and findings of the test substance in concern. Prior to obtaining related documents, we will conclude a nondisclosure agreement with client, and the provided information will be kept strictly confidential.
Conclusion of the Contract Study Agreement
After obtaining consent on study contents, study implementing organization, expenses etc., the contract study agreement will be concluded. The agreement includes confidence maintenance, implementing organization(s), the data of submission of the report, expenses, payment conditions, etc.
Preparation of Protocol
A draft protocol will be prepared after sufficient consultations. The protocol will be finalized after the client inspection and if required, correction of the draft protocol.
Implemention of Study
The study will be carried out in accordance with the protocol and the standard operating procedures. The results obtained will be reported as an interim report appropriately.
The draft report will be prepared based on the study results.After sufficient discussion with the client, the report will be finalized.
Submission of study results to an academic journal and presentation at an academic conference will be arranged by consultation. At the time of a document review by regulatory authorities, we will accompany clients to meetings upon request, and provide assistances on detailed data explanation, etc.
Archival of Documents, Data and Study Mateirals
All data, documents and storable samples obtained in the course of the study will be stored properly.