Instructions for Contract Research

Contact

Please contact the Sales & Marketing Department at Drug Development Solution Division. We will make arrangements with you as soon as possible
Sales & Marketing Department of Drug Development Solutions Division
TEL +81-3-3271-5634, FAX +81-3-3272-0700

Nondisclosure Agreement

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.

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.

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.

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.

Study Report

The draft report will be prepared based on the study results.After sufficient discussion with the client, the report will be finalized.

Application Support

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.

Preservation of Documents, Data, and Materials

All data, documents and storable samples obtained in the course of the study will be stored properly.