Drug Evaluation Committee Points to keep in mind to build and maintain a better cooperative relationship between pharmaceutical companies and contract research organizations Good Sponsor-CRO Partnership Practices; GSCPP
Clinical Evaluation Subcommittee Data Science Subcommittee Electronic Information Subcommittee
February 2014
It has been about 15 years since the enforcement of the new GCP (Good Clinical Practice), which legally positioned contract research organizations (CROs), and outsourcing to CROs has become an indispensable and important option for pharmaceutical companies (sponsors) to promote clinical development. In recent years, with the development of international joint development, there have been cases where new cooperative mechanisms (e.g., Preferred Vendor, Functional Service Provider) between the client and CRO have been introduced, and new cooperative relationships between the two have emerged.
In order for both pharmaceutical companies and CROs to promptly conduct highly reliable clinical trials as equal business partners, it is necessary to clarify the roles of each party and build a business model based on a good relationship of trust. It is important for the client to delegate authority appropriately to the CRO, clarify where the responsibility lies, and supervise the progress of work. By building a good relationship of trust between the two parties, it is possible to detect or prevent problems at an early stage, which will lead to more efficient operations for both parties.
Recently, the Japan Pharmaceutical Manufacturers Association (JPMA) and the Japan CRO Association (JCIA) have prepared this document based on discussions on points to keep in mind in order to build and maintain a better cooperative relationship as business partners, and thereby to conduct efficient business operations. This document includes monitoring and data management/statistical analysis services. We hope you will find this document useful in your daily work.
GSCPP Text
Attachment
Outline of Contract Research and Development (DM-Paper CRF)(40KB)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables