SERVICES

Clinical Monitoring

Investigate Optimal Treatment Dosage Responses

Full Range of Monitoring Services
  • Phase I–IV studies on drugs
  • Bioequivalence and bioavailability studies
  • Clinical studies on food supplements
  • Clinical studies on medical devices
  • Clinical studies on vaccines
Monitoring Procedures
  • Evaluation of the study progress
  • Review of protocol compliance
  • Review of CRFs and performance of SDV
  • Review of investigator’s file
  • Review of biological sample handling
  • Review of the investigational product(s)

Safety Monitoring in Phase 1 Clinical Trials

Quality Assurance
  • Identification of issues and implementation of corrective actions
  • Maintenance of frequent and direct communication plan
  • Maintenance of tracking reports
  • Regular site visits and assessments
  • Comprehensive documentation and reporting

Types of Monitoring Visits

Pre-Study Visit

A pre-study visit takes place after a potential PI indicates interest in a specific clinical trial. The purpose of this visit is to determine the site’s ability to conduct the study. The CRA evaluates:

  • PI responsibilities and qualifications
  • Study objectives and procedures
  • Site facilities and equipment
  • Staff qualifications

Initiation Visit

Once the PI agrees to participate and all regulatory approvals are in place, an initiation visit verifies that the site understands:

  • Study overview and eligibility criteria
  • GCP guidelines and regulations
  • Data forms and recording
  • Regulatory documentation
Close-Out Visit

The final visit ensures proper completion of all study activities:

  • Complete outstanding data and queries
  • Return or destroy unused products
  • Final review of study documents
  • Record retention plans
  • Results notification plans

For more information about our clinical monitoring services, please contact us at: info@convex.bg

Years of experience

Variety of clinical study designs

Dedicated clinical research unit

Top-notch results

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