About Us
CCRC Medtech (Shanghai) Co., Ltd
CCRC Medtech (Shanghai) Co., Ltd is a clinical research organization (CRO) focusing on medical device technology (i.e., medical devices, in vitro diagnostics, and AI technology) founded in 2015. We have provided professional clinical study services for a number of well-known domestic and foreign medical device companies and maintain a long-term close cooperation relationship with many clinical study institutions and investigators with rich experience accumulated in clinical trial projects in cardiovascular intervention, neurological intervention, oncology, respiratory intervention, artificial intelligence, robotics, orthopedics, dentistry, dermatology and other therapeutic fields.
CCRC is committed to providing customers with
one-stop services throughout the life cycle of device technology R & D
With the headquarter in Shanghai and an office in Beijing, our service covers more than 30 cities across China with nearly 300 employees. The members of our core management team have working experience in international first-line CROs or renowned device companies, with an average clinical experience of more than 15 years. CCRC is committed to providing customers with one-stop services throughout the life cycle of device technology R & D by providing a wide range of services from pre-marketing R & D, clinical registration to post-marketing, including clinical monitoring, project management, medical affairs, core laboratory, site management, biostatistics, data management, registration affairs, device safety management, medical translation and other services.
Medical Affairs & Safety Management
CCRC Medical Affairs team is mainly composed of three parts: medical writing, medical strategy and medical translation. Medical writers have extensive writing experience and provide medical writing and medical review services including writing of clinical trial related documents such as Protocol, IB, ICF and CSR, as well as medical review of CRF, SAP and SAR; The main responsibilities of medical advisors include writing of medical-related essential clinical study documents, medical monitoring of clinical trials, providing guidance to medical writers, and work with principal investigators to ensure the scientificity, integrity and feasibility of clinical studies in design, implementation, analysis, and summary, etc.; Medical translators have an educational background with bachelor’s degree and above in medical English, medicine English, translation, clinical medicine, and pharmacy, etc. with an average medical translation related working experience of 3 years. The responsibilities of medical translators are to provide professional translation and verification of clinical study and other device registration documents. Safety Management team has rich experience in safety management pf projects and provide all-round safety vigilance services for risk management of the whole life cycle of medical devices, including but not limited to medical device safety management, submission of expedited reports to regulatory authorities in China as well as other countries and regions, medical device safety-related training, safety system consultation, and assistance in establishing the drug/device vigilance system.
Clinical Execution
The Clinical Execution team of CCRC includes the clinical project management team and the clinical operation team, which have accumulated rich industry experience and diverse project experience. A "one-on-one project supervision support" will be established by designating a senior project manager to each project, with combined advantages of training system and role-basing accurate implementation, the clincial execution team aims to provide guidance and help in the trial operation as well as strict management and thorough assessment to the projects to ensure smooth implementation of clinical studies with controllable process of quality. CCRC will fully consider the actual needs of the client on project team members in communication, coordination, management and execution, and assign appropriate members with matched background by considering previous work experiences of the personnel and expertise in the therapeutic field, and build a professional and efficient project execution team for each clinical study project.
CCRC Clinical Execution team will strictly follow ICH-GCP, ISO14155, China Good Clinical Practice for Medical Devices and other applicable regulations, SOPs and the corresponding clinical study protocol in the clinical execution of the studies. The project management team will prepare a core guidance document "Project Management Plan" for the whole clinical trial management in the early stage of the clinical study, and regularly review and update it during the clinical trial. Periodic/non-periodic training will be done, including but not limited to, trainings on the protocol, clinical monitoring plan, medical monitoring plan, data management plan, and project-level guidelines. With flexible service mode, strict implementation according to the project timeline, strict control of multi-directional/dimensional quality, CCRC execution team can provide the best services to clients.
Regulatory Consultation
The regulatory consultation team is composed of the Director of Regulatory, Senior Regulatory Managers, Senior Regulatory Specialists and Regulatory think tank Specialists, with services covering passive devices, active devices, software devices, in vitro diagnostic reagents and equipments, and GMP system establishing. The regulatory think tank is maintained by a designated personnel, who will track the trends and interpretate the medical device regulations in China in real time.
Regulatory consultation team provides consultation services related to registration and marketing of medical devices in China, the United States and the European Union, as well as services on quality management system, submission and filing of human genetic resources, and regulations consultation. Team members are senior regulatory practitioners with years of practical experiences in regulatory authorities, testing agencies, or manufacturers. The regulatory consultation team have global regulatory support, medical device focusing, permeable regulatory thinking, and rich expert resources. With in-depth study and understanding of registration key points, guidelines and standards for technical review of product registration, regulatory policies and requirements, the regulatory consultation team can help enterprises to develop strategies, solve technical difficulties and review essential documents in preclinical and clinical studies.
Data Management
CCRC Data Management team consists of a Data Project Lead, Clinical Data Managers and Programmers. A senior data manager will be assigned to each project to ensure that data management is completed with high quality as planned.
The Data Management team is mainly responsible for writing of DMP, design of CRF, establishment and testing of EDC/IWRS, data cleaning, external data management, medical coding, database locking, and daily data query answering, etc. The adopted data management systems can fully support industry norms and has great advantages, which also meets the relevant requirements of CDISC clinical data exchange standard, China Good Clinical Practice, The American Clinical Laboratory Association, the Council for International Organizations of Medical Sciences, ISO9001 quality management system specifications, specifications of ISO17025 Testing And Calibration Laboratories, requirements from Medical Device Clinical Investigations (ISO 14155), and Validation System specification, etc.
Imaging Core Lab
The CCRC Imaging Core Laboratory，initially established in 2017，is a professional imaging core laboratory dedicated to clinical research in the field of pan-vascular intervention. It features world-wide recognized professional analysis software for pan-vascular imaging with complete quality-control systems. All analysts of the lab have clinical medicine or medical engineering background, and the main team members having more than ten years of experience have advanced study backgrounds in the CRF of New York city and Yale University School of Medicine. They have helped many domestic and foreign device manufacturers to successfully obtain registration certificates. All team members have obtained national GCP-related qualification certificates.
Since its establishment, the CCRC Imaging Core Laboratory has participated in the image analysis of several pre-marketing, post-marketing and scientific research clinical trial projects, among which a project was published in the New England Journal of Medicine in 2020.05, which ranked 2nd in the "Top 10 Medical Science and Technology News in China of 2020".
SMO
Taking the study institution as the center, and coordinating of all parties of the projects, ROCK Site Network (Shanghai) Co., Ltd. is committed to providing integrated SMO services for clinical studies and to building an effective communication bridge between the sponsors and the investigators. Luoke is founded to meet the needs of clinical studies, with the study sites as the center of working and a central teamwork mode to promote a full play to the efficiency of CRC with the advantages of systematic training and well-established quality management system. Insides the company, Luoke coordinates the establishment of a closed loop of business development, clinical operation, medical support, data statistics, quality training and accelerated subjects enrollment; and outsides the company, Luoke aims to become one of the industrial leaders by building a professional platform for medical device clinical study and providing customized solutions based on the business needs.
CCRC Teams
Medical Affairs & Safety Management
CCRC Medical Affairs team is mainly composed of three parts: medical writing, medical strategy and medical translation. Medical writers have extensive writing experience and provide medical writing and medical review services including writing of clinical trial related documents such as Protocol, IB, ICF and CSR, as well as medical review of CRF, SAP and SAR; The main responsibilities of medical advisors include writing of medical-related essential clinical study documents, medical monitoring of clinical trials, providing guidance to medical writers, and work with principal investigators to ensure the scientificity, integrity and feasibility of clinical studies in design, implementation, analysis, and summary, etc.; Medical translators have an educational background with bachelor’s degree and above in medical English, medicine English, translation, clinical medicine, and pharmacy, etc. with an average medical translation related working experience of 3 years. The responsibilities of medical translators are to provide professional translation and verification of clinical study and other device registration documents. Safety Management team has rich experience in safety management pf projects and provide all-round safety vigilance services for risk management of the whole life cycle of medical devices, including but not limited to medical device safety management, submission of expedited reports to regulatory authorities in China as well as other countries and regions, medical device safety-related training, safety system consultation, and assistance in establishing the drug/device vigilance system.
Clinical Execution
The Clinical Execution team of CCRC includes the clinical project management team and the clinical operation team, which have accumulated rich industry experience and diverse project experience. A "one-on-one project supervision support" will be established by designating a senior project manager to each project, with combined advantages of training system and role-basing accurate implementation, the clincial execution team aims to provide guidance and help in the trial operation as well as strict management and thorough assessment to the projects to ensure smooth implementation of clinical studies with controllable process of quality. CCRC will fully consider the actual needs of the client on project team members in communication, coordination, management and execution, and assign appropriate members with matched background by considering previous work experiences of the personnel and expertise in the therapeutic field, and build a professional and efficient project execution team for each clinical study project.
CCRC Clinical Execution team will strictly follow ICH-GCP, ISO14155, China Good Clinical Practice for Medical Devices and other applicable regulations, SOPs and the corresponding clinical study protocol in the clinical execution of the studies. The project management team will prepare a core guidance document "Project Management Plan" for the whole clinical trial management in the early stage of the clinical study, and regularly review and update it during the clinical trial. Periodic/non-periodic training will be done, including but not limited to, trainings on the protocol, clinical monitoring plan, medical monitoring plan, data management plan, and project-level guidelines. With flexible service mode, strict implementation according to the project timeline, strict control of multi-directional/dimensional quality, CCRC execution team can provide the best services to clients.
Regulatory Consultation
The regulatory consultation team is composed of the Director of Regulatory, Senior Regulatory Managers, Senior Regulatory Specialists and Regulatory think tank Specialists, with services covering passive devices, active devices, software devices, in vitro diagnostic reagents and equipments, and GMP system establishing. The regulatory think tank is maintained by a designated personnel, who will track the trends and interpretate the medical device regulations in China in real time.
Regulatory consultation team provides consultation services related to registration and marketing of medical devices in China, the United States and the European Union, as well as services on quality management system, submission and filing of human genetic resources, and regulations consultation. Team members are senior regulatory practitioners with years of practical experiences in regulatory authorities, testing agencies, or manufacturers. The regulatory consultation team have global regulatory support, medical device focusing, permeable regulatory thinking, and rich expert resources. With in-depth study and understanding of registration key points, guidelines and standards for technical review of product registration, regulatory policies and requirements, the regulatory consultation team can help enterprises to develop strategies, solve technical difficulties and review essential documents in preclinical and clinical studies.
Data Management
CCRC Data Management team consists of a Data Project Lead, Clinical Data Managers and Programmers. A senior data manager will be assigned to each project to ensure that data management is completed with high quality as planned.
The Data Management team is mainly responsible for writing of DMP, design of CRF, establishment and testing of EDC/IWRS, data cleaning, external data management, medical coding, database locking, and daily data query answering, etc. The adopted data management systems can fully support industry norms and has great advantages, which also meets the relevant requirements of CDISC clinical data exchange standard, China Good Clinical Practice, The American Clinical Laboratory Association, the Council for International Organizations of Medical Sciences, ISO9001 quality management system specifications, specifications of ISO17025 Testing And Calibration Laboratories, requirements from Medical Device Clinical Investigations (ISO 14155), and Validation System specification, etc.
Imaging Core Lab
The CCRC Imaging Core Laboratory，initially established in 2017，is a professional imaging core laboratory dedicated to clinical research in the field of pan-vascular intervention. It features world-wide recognized professional analysis software for pan-vascular imaging with complete quality-control systems. All analysts of the lab have clinical medicine or medical engineering background, and the main team members having more than ten years of experience have advanced study backgrounds in the CRF of New York city and Yale University School of Medicine. They have helped many domestic and foreign device manufacturers to successfully obtain registration certificates. All team members have obtained national GCP-related qualification certificates.
Since its establishment, the CCRC Imaging Core Laboratory has participated in the image analysis of several pre-marketing, post-marketing and scientific research clinical trial projects, among which a project was published in the New England Journal of Medicine in 2020.05, which ranked 2nd in the "Top 10 Medical Science and Technology News in China of 2020".
SMO
Taking the study institution as the center, and coordinating of all parties of the projects, ROCK Site Network (Shanghai) Co., Ltd. is committed to providing integrated SMO services for clinical studies and to building an effective communication bridge between the sponsors and the investigators. Luoke is founded to meet the needs of clinical studies, with the study sites as the center of working and a central teamwork mode to promote a full play to the efficiency of CRC with the advantages of systematic training and well-established quality management system. Insides the company, Luoke coordinates the establishment of a closed loop of business development, clinical operation, medical support, data statistics, quality training and accelerated subjects enrollment; and outsides the company, Luoke aims to become one of the industrial leaders by building a professional platform for medical device clinical study and providing customized solutions based on the business needs.
Partners
Investor
Hygeia Capital
Introduction
Hygeia Capital was founded by Mr. Wang Kai in 2016 and is headquartered in Shanghai. It is a private equity investment fund and venture capital fund management institution that implements market-oriented operation and is based on the two-wheeled investment strategy of "active investment" + "in-depth investment banking service", focusing on the medical and health industry.
