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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

For more information

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