Site Management Organization
About Service
C&R SMO is a site management organization (SMO) that provides clinical trials -related services based on its skilled experience and knowledge.
Site Management Service
- Subject enrollment and training
- Site administration service
- Project training and status management
- Audit and inspection preparation
- Management of clinical trial supplies
CRC Out-sourcing Service
- Project schedule management
- Subject training
- Subject management
- Laboratory management
- AE/SAE reporting and follow-up
- Source documents preparation
- CRF data entry and management
- Monitoring, Inspection, Audit preparation and response
- Conducting tasks related to Clinical trail
- Essential documents archiving and management
Subject Recruitment & Support Service
- Identifying the causes of low enrollment rate
- Prediction of potential dropout and development of countermeasures
Feasibility Study Service
- Prompt completion of feasibility visit/report
- Communication with Regulatory agency and IRBs
IRB Reporting Service
- Initial IRB submission, Amendment IRB submission, Continuous submission
- Close out IRB submission, CSR IRB submission
- SAE/SUSAR Report
- Deviation/Violation Report
DM/STAT Service
- PMS (Post-Marketing Study) / OS (Observational Study) / IIT (Investigator-Initiated Trials) Data Management Process
- Data verification
- Query generation
- Medical coding
- SAE reconciliation
- STAT consulting
Professional CRC with Medical Expertise
- Professional medical knowledge and clinical experience-based services consisting of RNs
- Develop an overall understanding of clinical trials through specialized training on Medical Director’s protocol diseases
Accelerate clinical trials with efficient systems
- Internal discussions and solution derivation system, focusing on registration rate, screening, and ISSUE
- Senior – Junior CRC matching program facilitates
- Establish a direct reporting system for immediate management of important site issues
Instant Communication
- Operate a 24-hour emergency contact network to promptly respond to requests from participants and handle issues such as SAE, SUSAR
- Achieve optimal clinical trial results with a team head and project manager, who possess extensive practical experience and knowledge in clinical trials and trained CRCs
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