Regulatory & Ethics Support
Regulatory strategy, submissions, and ethics committee coordination that keep your study compliant and participants protected.
Calebyte BioSolutions
Pharmacovigilance
Safety reporting, adverse event documentation, and pharmacovigilance processes that protect participants and meet reporting obligations.
Overview
About Pharmacovigilance
Participant safety is the first priority of any clinical study. Robust safety reporting depends on well-trained site teams, clear processes, and timely coordination between sites, sponsors, and authorities.
We support sponsors and sites in establishing and running pharmacovigilance processes for clinical research, from adverse event documentation at the site to coordinated safety data flows and reporting.
Challenges addressed
The problems we help you solve
Under-reporting
Adverse events that go unrecognized or undocumented at the site level.
Tight reporting timelines
Expedited reporting obligations that require fast, coordinated action.
Fragmented safety data
Safety information held across sites, systems, and organizations.
Process maturity
Sites and sponsors new to pharmacovigilance requirements in the region.
Capabilities
How we support you
Specialized support across the full scope of Pharmacovigilance.
Safety reporting support
Support for timely, complete safety reports to sponsors and authorities.
Adverse event documentation
Training and tools for accurate adverse event capture at sites.
Safety data coordination
Coordinate safety data flows between sites, sponsors, and safety teams.
Pharmacovigilance processes
Design and document PV processes and SOPs for clinical research.
Our approach
A structured, collaborative process
- 1
Establish
Define safety processes, roles, and reporting lines.
- 2
Train
Prepare site teams to recognize and document events.
- 3
Coordinate
Manage safety data flows and reporting timelines.
- 4
Review
Monitor process performance and improve continuously.
Benefits
What you can expect
Participant protection
Safety signals captured and acted on.
Timely reporting
Obligations met within required timelines.
Complete safety records
Consistent documentation across sites.
Mature processes
PV capability that strengthens over time.
Related services
Explore related services
Data Management & Biostatistics
Clinical data management, quality control, biostatistics, and analytics that turn study data into reliable evidence.
Clinical Trial Services
End-to-end operational support from feasibility and site identification through study start-up, monitoring, and coordination.
Planning a clinical study in Africa?
Tell us about your goals and we will help you identify the right next step.