Drug Evaluation Committee Building an Effective Collaborative Structure between Pharmaceutical Companies and CROs From an Outsourcing Relationship to a Mutually Trusted Partner
Clinical Evaluation Subcommittee
September 2016
Almost 20 years have passed since the GCP Ministerial Ordinance defined the term "contract research organization" (hereinafter referred to as "CRO"). While pharmaceutical companies and CROs have accumulated know-how for effective collaboration, there are still ongoing discussions regarding contract research organizations (CROs), and it is apparent that some issues remain. In recent years, the collaboration system, including the form of contract, has been diversifying, with pharmaceutical companies and specific CROs concluding comprehensive contracts.
Therefore, in order to promote effective collaboration in outsourcing with CROs, the FY2015 Task Force 2 of the Clinical Evaluation Subcommittee of the Committee on Drug Evaluation, in addition to organizing the diversified contracting methods, reexamined what both parties should do to overcome the challenges in outsourcing management, and compiled the results in the form of a report. The report proposes a common language and management tools that can be utilized in business by many parties involved, including liaison officers, managers and leaders in charge of managing operations, and other personnel at both pharmaceutical companies and CROs.
We hope that this report will further develop the commissioning relationship between pharmaceutical companies and CROs, and help to strengthen drug development capabilities and develop the clinical trial environment in Japan.
Results of the survey on the environment for contracted development services
Management Tools for Outsourced Development
Summary of previous reports on contracted development services
Appendix 5: Past Deliverables from the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables