Drug Evaluation Committee Building Effective Collaboration between Pharmaceutical Companies and CROs From Outsourced Relationships to Trusted Partners
Clinical Evaluation Subcommittee
September 2016
Almost 20 years have passed since the GCP Ministerial Ordinance defined contract research organizations (hereafter referred to as CROs). 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, the Drug Evaluation Committee's Clinical Evaluation Subcommittee's 2015 Task Force 2 has compiled a report on what both parties should do to overcome the challenges of outsourcing management, in addition to organizing the diversified contracting methods, in order to promote effective outsourcing collaboration with CROs. 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.