Trial management is at the core of our services. Since 1991, Convex has organized and managed clinical trials for hundreds of drugs, devices, and diagnostics ranging in size from a single-centre to multi-centre trials involving thousands of patients.
The key elements of our strategy include:
- Negotiation with medical institutions, laboratories, courier companies, drug dispensary companies, customs, etc., on behalf of the Sponsor.
- Meticulous Site Identification and Assessment.
- Expeditious Regulatory Approvals.
- Continuous communication with Regulatory Authorities throughout a clinical trial.
- Assiduous Site Training, Initiation, and Close-out.
- Operative Clinical Monitoring Plans.
- Strict Study Materials Accountability.
- Considerate Query Resolution.
- Investigator Meeting Planning, Coordination and Management.
- Assistance during audit procedures.
- Arrangement of the supply of drugs and materials for the purposes of the trial within Bulgaria.
- Payment of fees to Regulatory Authorities, Investigators, medical institutions, laboratories, etc. for Phase II–IV clinical trials.
- Coordination of courier companiesactivities, including customs affairs (import and export licenses).
- Providing insurance policy for the Clinical Research Subjects and medical staff.