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Clinical Operation

About service

Since the early phase clinical research is a critical stage in which nonclinical development is transferred to the next clinical development, it has significant implications in terms of efficient product development and reduction in opportunistic costs. C&R Research offers comprehensive services in the early phase clinical research, including consulting, medical writing, regulatory affairs, data management, and biostatistics. In particular, through our close collaboration with major research institutes with proven competitiveness in the initial clinical research process, accurate clinical results can be delivered to clients in a cost-effective manner.

Phase 0 – Phase IIA

  • Early-Phase Trial Designing
  • Protocol Development
  • Trial-Related Document Development: CRF (Case Report Form), ICF (Informed Consent Form), Various Forms, etc.
  • Patient-Based Early-Phase Trial Research Team Construction
  • New Therapeutics Regulatory Affairs: Cell Therapy, Gene Therapy, etc.
  • Clinical Trial Participation as an Investigator
  • CRF Fill-Up + QC (Quality Control) /QA (Quality Assurance) Activities)
  • Statistical Analysis and CSR (Case Study Report) Writing

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

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

Proven expertise in early phase clinical research

Sufficient capacity to carry out the early phase clinical study is a critical factor to determine time and costs in the whole development process of medicinal products. Overall, C&R Research’s professionals provides customized solutions in the delivery of early-phase trial designs, clinical monitoring, and data management.

Vast experience

In the early phase clinical research, C&R Research possesses extensive experience in conducting complex studies across more than 25 indications. Through closer collaboration with renowned research organizations in Asian countries including Korea, C&R Research provides standardized early phase services.

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