Project Management

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.

convex-project-mgmtThe 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.