Monitoring

Capabilities


We firmly believe that robust clinical monitoring is vital for clinical trials to yield valid and regulatory adequate clinical data. With a crew of experienced and qualified CRAs, we ensure high-quality data review and effective communication with study sites and sponsors. We can achieve this through a deeper understanding of protocols, standard operating procedures (SOPs), and precise knowledge of ICH-GCP and all other applicable regulatory guidelines.

Clinical Monitoring Services:

  • Investigator Identification and Site selection
  • Site Qualification Visits
  • Devise plans and execute Investigator Meetings
  • Site Initiation Visits and Site staff Training
  • Informed Consent Form review
  • Interim and Routine Monitoring Visits
  • Source data verification and CRF data review
  • Monitor Adverse Event reporting
  • Perform drug and/or device accountability
  • Patient unblinding
  • Ensure regulatory compliance
  • Close Out /Study Termination Visits

Risk based monitoring


To minimize risks in investigation quality, secure human subject and ensure data integrity - we at CBCC have efficient regulatory authorities to recognize the potential of RBM to improve the execution of clinical trials. The monitoring aids in identifying as well as mitigating risks and challenges during the early stage of clinical development. The following methodologies implemented:

  • Build Quality by Design into trials
  • Assess early and ongoing risks
  • Focus on Critical Processes and Critical Data
  • Use Risk Indicators and Thresholds
  • Adjust monitoring activities based on the identified issues and risks

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