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)
Reviewing clinical study data and ECG traces on a tablet

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
Visitors speaking with reception staff at Convex

Study staff discussing participation with prospective volunteers

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
Corridor leading to a clinical participant room

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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