The Korea National Enterprise for Clinical Trials (KoNECT) released the results of its Clinical Research Organization (CRO) certification evaluation for this year and announced the newly certified organizations on Wednesday.
As a result of the evaluation, the state agency certified C&R Research as an innovative CRO and D2S as a small but strong CRO.
C&R Research was recognized as an innovative CRO by winning the highest score ever in the project management and data management (DM)/statistics (STAT)areas.
Accordingly, C&R Research has been recognized for its excellence as the only CRO in Korea to achieve certification in all specialty areas of the CRO certification assessment. The company was also certified in 2014 (for project management), 2015 (site management, medical writing), 2016 (DM/STAT), and 2020 (project management, DM/STAT).
D2S won recognition for its expertise in DM/STAT and has been certified as a small but strong CRO.
The small but strong CRO certification was introduced in 2022 to recognize outstanding CROs that are too small to qualify for the innovative CRO certification but have a high level of expertise in a specific field. Clinical CROs with domestic capital exceeding 50 percent and annual sales of 500 million won ($373,000) to 3 billion won, or 10 to 50 employees, are eligible for certification.
"Seeing C&R Research and D2S pass the CRO certification assessment, we feel that the capabilities of domestic CROs are gradually increasing," KoNECT Chairman Park In-seok said. "We will continue to foster the domestic CRO industry, analyze major CRO industries in Asia, and support multinational clinical trial orders to help the domestic CRO market become an Asian hub."
The CRO certification assessment is a project operated by the agency to verify and strengthen the capabilities of CROs through global-level certification assessment by system and specialty area.
Under Article 18(2) of the Special Act on Fostering and Supporting the Pharmaceutical Industry, the system is designed to increase the trust of domestic and foreign pharmaceutical companies in domestic CROs and strengthen the global competitiveness of the CRO industry by checking the research capabilities of domestic CROs and certifying their specialized areas.
CROs applying for certification will be evaluated on their systems (organization, manpower, facilities, and quality management) and areas of expertise (site management, DM/STAT, project management, medical writing) and receive consulting based on global standards during the evaluation process.
The certified organizations will receive various benefits, including domestic and international promotion as a representative CRO in Korea, priority recommendation when linking with pharmaceutical companies for clinical trials, priority training for employees, support for participation in clinical trial-related events, domestic and international information on clinical trials, and preferential treatment when conducting clinical trial support projects.