서비스 개요 (About service)
초기 임상은 비임상 단계에서 임상 단계로 진입하는 중요한 단계로써 의약품 개발의 효율성과 기회 비용 절감에 있어서 큰 의미가 있습니다. ㈜씨엔알리서치는 초기임상에 있어 컨설팅을 포함하여 Medical Writing, Regulatory Affair, Data Management, Biostatistics에 있어 포괄적인 초기임상 서비스를 제공하고 있습니다. 특히, 초기 임상 수행을 위한 경쟁력이 검증된 주요 연구 기관들과의 협업을 통하여 빠르고 정확한 임상 결과를 합리적인 조건으로 제공 가능합니다.
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
초기 임상 전문성
초기 임상 단계의 전문성 기반 수행 역량은 의약품 임상 개발 전과정에 있어 시간 및 비용의 효율성을 결정하는 중요한 요소 입니다. 씨엔알리서치의 전문가들은 임상시험 디자인, 임상 모니터링, 데이터 관리에 걸쳐 전반적인 맞춤형 솔루션을 제공해 드리고 있습니다.
폭 넓은 경험
씨엔알리서치는 25개가 넘는 폭넓은 적응증의 초기 임상 단계에 있어서 수행 경험을 보유하고 있으며, 한국 및 아시아 지역의 주요 연구 기관들과의 밀접한 협업을 통하여 표준화된 서비스를 제공하고 있습니다.
자세한 내용은 이곳으로 문의하여 주시기 바랍니다.
추가정보 (For more information)