About Us
CCRC Medtech (Shanghai) Co., Ltd
CCRC Medtech (Shanghai) Co., Ltd., founded in 2015, is a clinical research organization (CRO) specializing in the field of medical device technology (i.e., medical devices, in vitro diagnostics, and AI technology). We have provided professional services on clinical studies for a number of well-known domestic and foreign medical device companies, and established a long-term close cooperative relationship with many clinical sites and investigators with rich experience in clinical trial projects in therapeutic fields such as cardiovascular intervention, neurointervention, oncology, respiratory intervention, artificial intelligence, robotics, orthopedics, dentistry, and dermatology.
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, we have nearly 300 employees providing service for more than 30 cities across China. All 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, and our services cover from pre-marketing R&D, clinical trial and registration to post-marketing, including clinical monitoring, project management, medical affairs, core laboratory, site management, biostatistics, data management, regulatory affairs, device safety management, medical translation, etc.
Medical Affairs & Safety Management
The Medical Affairs team of CCRC is mainly composed of three parts: medical writing, medical strategy and medical translation. The medical writers have extensive writing experience and provide medical writing and medical review services including writing of clinical trial related documents such as Protocol, Investigator’s Brochures (IBs), Informed Consent Form (ICF) and Clinical Study Reports (CSRs), as well as medical review of Case Report Forms (CRFs), Statistical Analysis Plans (SAPs) and Statistical Analysis Reports (SARs); The main responsibilities of medical advisors include writing of core medical-related documents, medical monitoring of clinical trials, and working with principal investigators to ensure the scientificity, integrity and feasibility of clinical studies in terms of design, implementation, analysis, and summary, etc.; The medical translators hold bachelor’s degree and above in medical English, pharmaceutical English, translation, clinical medicine, and pharmacy, etc. with an average of 3 years of experience in medical translation, and are mainly responsible for providing professional translation of other documents related to clinical trials and registration of medical devices.
The Safety Management team is skilled and experienced in safety management and can provide all-round safety vigilance services for the lifecycle risk management of medical devices, including but not limited to safety management of medical devices, submission of expedited reports to regulatory authorities in both China and other countries or regions, safety-related trainings on medical devices, safety system consultation, and assistance in establishing the pharmacovigilance system/medical devices vigilance system, etc.
Clinical Execution
The Clinical Execution team of CCRC includes clinical project management team and the clinical operation team, which have accumulated professional industry experience and diversified project experience. With a perfect internal training system established to ensure role-based accurate execution, CCRC implements"one-on-one project supervision support" by designating a senior project manager to each project, with the aim to provide guidance and help in the trial operation as well as strict management and thorough assessment of the projects to ensure smooth execution of clinical studies with controllable process of study quality. CCRC will fully consider the client's actual needs on project team members in terms of communication, coordination, management and execution, and assign appropriate members with matched background taking into account the previous work experiences of the personnel and expertise in the therapeutic field to 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 review and update it on a regular basis during the clinical trial. At CCRC, periodic/non-periodic trainings will be conducted, 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 and multi-directional/dimensional quality control, CCRC execution team can provide the best services to clients.
Regulatory Affairs
The regulatory affairs team is composed of the regulatory affairs director, senior regulatory affairs managers, senior regulatory specialists, and regulatory think tank specialists, providing 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 expert, who will track the trends and interpret the medical device regulations in China in real time. The regulatory affairs team provides consultation services related to registration and marketing of medical devices in China, the United States and the European Union, services on quality management system, submission and filing of human genetic documents, and services on regulations consultation.
Team members are senior regulatory practitioners with years of practical experiences in regulatory authorities, testing agencies, or manufacturers. The regulatory affairs team boast of global regulatory support, medical device focusing, permeable regulatory thinking, and rich expert resources. With in-depth study and understanding of essentials, guidelines and standards for technical review of product registration, regulatory policies and requirements, the regulatory affairs team can help enterprises 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 high-quality data management as scheduled.
The Data Management team is mainly responsible for writing of DMPs, design of CRFs, establishment and testing of EDC/IWRS, data cleaning, external data management, medical coding, database locking, and daily reply to data questions, etc. The data management system fully supports industry norms and complies with "Clinical Data Interchange Standards" of CDISC, "Good Clinical Practice" in China, requirements from the Clinical and Laboratory Standards Institute and the Council for International Organizations of Medical Sciences, specifications of ISO9001 "Quality Management System" and ISO17025 Testing and Calibration Laboratories, requirements from "Clinical Investigation of Medical Devices (ISO 14155)", and Validation System specifications, etc.
Imaging Core Lab
CCRC Imaging Core Lab, was initially established in 2017. As a professional imaging core laboratory dedicated to clinical studies in the field of pan-vascular intervention, the lab boasts of its perfect quality system and internationally accepted professional analysis software for pan-vascular imaging. The analysts have a background in clinical medicine or medical engineering, and the main members of the team have a further study background in CRF and Yale University School of Medicine in the United States, with more than ten years of experience. They have helped many domestic and foreign device manufacturers successfully obtain registration certificates, and all the team members have obtained the China GCP-related qualification certificate.
The Imaging Core Lab of CCRC has participated in the image analysis for a number of pre-marketing and post-marketing clinical trials as well as projects covering scientific research since its establishment, one of which was published in The New England Journal of Medicine in May 2020 and ranked second in "China's Top Ten Medical Science and Technology News in 2020".
SMO
Taking the study institution as the center, and coordinating the cooperation of all parties in the projects, Shanghai ROCK Site Network 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. ROCK aims to meet the needs of clinical studies and maximize the efficiency of CRC by taking the study sites as the center and applying central teamwork mode to promote project execution. At ROCK, we have systematic trainings and well-established quality management system. Internally, ROCK coordinates the establishment of a closed loop of business development, clinical operation, medical support, data statistics, quality training, and accelerated subjects enrollment; externally, ROCK aims to become one of the industrial leaders by building a professional platform for clinical studies on medical devices and providing customized and compliant solutions based on the business needs.
CCRC Teams
Medical Affairs & Safety Management
The Medical Affairs team of CCRC is mainly composed of three parts: medical writing, medical strategy and medical translation. The medical writers have extensive writing experience and provide medical writing and medical review services including writing of clinical trial related documents such as Protocol, Investigator’s Brochures (IBs), Informed Consent Form (ICF) and Clinical Study Reports (CSRs), as well as medical review of Case Report Forms (CRFs), Statistical Analysis Plans (SAPs) and Statistical Analysis Reports (SARs); The main responsibilities of medical advisors include writing of core medical-related documents, medical monitoring of clinical trials, and working with principal investigators to ensure the scientificity, integrity and feasibility of clinical studies in terms of design, implementation, analysis, and summary, etc.; The medical translators hold bachelor’s degree and above in medical English, pharmaceutical English, translation, clinical medicine, and pharmacy, etc. with an average of 3 years of experience in medical translation, and are mainly responsible for providing professional translation of other documents related to clinical trials and registration of medical devices.
The Safety Management team is skilled and experienced in safety management and can provide all-round safety vigilance services for the lifecycle risk management of medical devices, including but not limited to safety management of medical devices, submission of expedited reports to regulatory authorities in both China and other countries or regions, safety-related trainings on medical devices, safety system consultation, and assistance in establishing the pharmacovigilance system/medical devices vigilance system, etc.
Clinical Execution
The Clinical Execution team of CCRC includes clinical project management team and the clinical operation team, which have accumulated professional industry experience and diversified project experience. With a perfect internal training system established to ensure role-based accurate execution, CCRC implements"one-on-one project supervision support" by designating a senior project manager to each project, with the aim to provide guidance and help in the trial operation as well as strict management and thorough assessment of the projects to ensure smooth execution of clinical studies with controllable process of study quality. CCRC will fully consider the client's actual needs on project team members in terms of communication, coordination, management and execution, and assign appropriate members with matched background taking into account the previous work experiences of the personnel and expertise in the therapeutic field to 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 review and update it on a regular basis during the clinical trial. At CCRC, periodic/non-periodic trainings will be conducted, 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 and multi-directional/dimensional quality control, CCRC execution team can provide the best services to clients.
Regulatory Affairs
The regulatory affairs team is composed of the regulatory affairs director, senior regulatory affairs managers, senior regulatory specialists, and regulatory think tank specialists, providing 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 expert, who will track the trends and interpret the medical device regulations in China in real time. The regulatory affairs team provides consultation services related to registration and marketing of medical devices in China, the United States and the European Union, services on quality management system, submission and filing of human genetic documents, and services on regulations consultation.
Team members are senior regulatory practitioners with years of practical experiences in regulatory authorities, testing agencies, or manufacturers. The regulatory affairs team boast of global regulatory support, medical device focusing, permeable regulatory thinking, and rich expert resources. With in-depth study and understanding of essentials, guidelines and standards for technical review of product registration, regulatory policies and requirements, the regulatory affairs team can help enterprises 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 high-quality data management as scheduled.
The Data Management team is mainly responsible for writing of DMPs, design of CRFs, establishment and testing of EDC/IWRS, data cleaning, external data management, medical coding, database locking, and daily reply to data questions, etc. The data management system fully supports industry norms and complies with "Clinical Data Interchange Standards" of CDISC, "Good Clinical Practice" in China, requirements from the Clinical and Laboratory Standards Institute and the Council for International Organizations of Medical Sciences, specifications of ISO9001 "Quality Management System" and ISO17025 Testing and Calibration Laboratories, requirements from "Clinical Investigation of Medical Devices (ISO 14155)", and Validation System specifications, etc.
Imaging Core Lab
CCRC Imaging Core Lab, was initially established in 2017. As a professional imaging core laboratory dedicated to clinical studies in the field of pan-vascular intervention, the lab boasts of its perfect quality system and internationally accepted professional analysis software for pan-vascular imaging. The analysts have a background in clinical medicine or medical engineering, and the main members of the team have a further study background in CRF and Yale University School of Medicine in the United States, with more than ten years of experience. They have helped many domestic and foreign device manufacturers successfully obtain registration certificates, and all the team members have obtained the China GCP-related qualification certificate.
The Imaging Core Lab of CCRC has participated in the image analysis for a number of pre-marketing and post-marketing clinical trials as well as projects covering scientific research since its establishment, one of which was published in The New England Journal of Medicine in May 2020 and ranked second in "China's Top Ten Medical Science and Technology News in 2020".
SMO
Taking the study institution as the center, and coordinating the cooperation of all parties in the projects, Shanghai ROCK Site Network 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. ROCK aims to meet the needs of clinical studies and maximize the efficiency of CRC by taking the study sites as the center and applying central teamwork mode to promote project execution. At ROCK, we have systematic trainings and well-established quality management system. Internally, ROCK coordinates the establishment of a closed loop of business development, clinical operation, medical support, data statistics, quality training, and accelerated subjects enrollment; externally, ROCK aims to become one of the industrial leaders by building a professional platform for clinical studies on medical devices and providing customized and compliant solutions based on the business needs.
Qualification
High-tech Enterprise Certificate
Certified to ISO 9001
Member of China Association For Medical Devices Industry
Shanghai "specialized and special new" small and medium enterprises
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.
