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Clinical Operation

About service

C&R Research has conducted more than 1,200 trials for nearly two decades. Our optimized clinical trial designs and high-quality clinical operation services customized to the needs of clients are delivered by a dedicated team of professionals with extensive experience and know-how across a broad range of therapeutic areas. In particular, C&R Research boasts project managers and CRAs with years of practical experience and expertise in clinical sector, as well as in-house medical and regulatory experts. We are committed to providing the most fast and accurate clinical trial services that are compliant to KGCP and ICH-GCP guidelines, and to all International Standards.

Regulatory and Medical Writing Services

  • Management of IND submission
  • Document Coordination including publishing for eCTD compliance
  • Investigator’s brochures
  • Protocol development
  • Informed consents and assents
  • Investigational medicinal product dossiers
  • Regulatory meeting briefing packages
  • Clinical study reports (Phase I, II, III, and IV)
  • Safety narratives
  • Development Safety Update Reports
  • Periodic Safety Update Reports
  • Risk Management Plans
  • Data and safety monitoring board (DSMB) charters and reports
  • Interim data summaries

Our clinical monitoring and site management services

  • Site identification and feasibility
  • Review of inclusion exclusion criteria and the proper consenting of all subjects
  • Site selection and qualification visits
  • Investigator’s meeting
  • Assist with obtaining approval from local Ethics Committees and Institutional Review Boards
  • Managing subject recruitment
  • Review of quality systems at the site and ensuring all sites are audit ready
  • Initiation, interim monitoring, and study closure visits
  • Essential document collection, review and processing
  • Good Clinical Practice monitoring, including motivational and training visits
  • CAPA plan development and implementation
  • Source documentation review, CRF review and query resolution
  • Accountability for all study documents and materials
  • Communication with sites
  • Study specific training to site personnel
  • Review of Investigational Product accountability and storage
  • Review of safety information of all subjects
  • Logging and correcting protocol deviations
  • Project management and Monitoring study progress
  • Database lock and study close out
  • Mass mailings and newsletters to sites

Central Monitoring

  • Risk-based monitoring and Report
  • Effectively identify
  • Mitigate and Monitor risk

Data Management

  • Data management services (eCRF design, specification and completion guidelines)
  • Statistical and Clinical reporting services
  • EDC Systems – Lead trial™
  • Supporting -eMVR™, eTMF, IWRS

Clinical operation team with expertise under systemized organizational structure

C&R Research’s clinical operation team has extensive experience across a wide range of therapeutic areas and clinical trial insight. Boasting the largest organization in C&R Research, the team has experienced clinical research managers, project managers, and highly trained CRAs who play pivotal roles in overall clinical development process. Through the efficient communication process between all related departments, our clinical operation team provides clinical trial services customized and optimized specifically to the needs of clients and project nature.

Global-level clinical motoring capability

C&R Research’s clinical operation team has accumulated therapeutic area expertise across all phases of clinical development, coupled with a lot of inspections and audits. As a leading clinical research organization (CRO) in Korea, we have successfully conducted a significant number of studies until this date and in addition, our experts have ceaselessly developed a wide range of clinical monitoring capabilities. In particular, through participation in many multinational clinical trials via partnership with a global CRO from 2007, our team of skilled professionals has further strengthened their communication capabilities and global electronic data capture (EDC) system. This array of experience has enabled us to provide global-level clinical monitoring services.

Development of project management system for clinical trials in Asia

To seek an effective management of clinical trials in Asia for clients at home and abroad, C&R Research has developed an exclusive project management system. Our experienced clinical research managers and project managers have spared no effort, via strategic communication and know-how between global partners and local branches, to provide clear value to clients’ products in Asian markets, by overcoming cultural and regulatory differences in each local area and placing a top priority on integrated project management and training for CRAs in each local area.

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