Post-Market Studies & Lifecycle Evidence
We generate post-market evidence that supports safety, regulatory commitments, and lifecycle decisions.
From Surveillance to Lifecycle Evidence
We support organizations with post-market evidence generation through surveillance, follow-up studies, registries, and post-authorization programs that strengthen patient safety, meet regulatory obligations, and sustain confidence across the product lifecycle.
Our approach begins with the specific post-market question that needs to be answered, whether related to safety, performance, benefit-risk, regulatory commitments, or long-term product use. From there, we design the right evidence strategy, identify fit-for-purpose data sources, and implement study frameworks that generate credible, decision-ready insights.
Core Elements
Post-Market Study & Lifecycle Evidence Capabilities
We design and support post-market studies and lifecycle evidence programs that strengthen safety monitoring, evaluate real-world performance, meet regulatory commitments, and inform ongoing product decisions.
Core Post-Market Study & Lifecycle Evidence Capabilities
- We design and support post-market studies and lifecycle evidence programs that strengthen safety monitoring, Evaluate real-world performance, Meet regulatory commitments, Inform ongoing product decisions
Signal Detection & Pharmacovigilance Analytics
- Identify, Assess, Monitor emerging safety signals using real-world safety data, Literature, Pharmacovigilance analytics
PASS & Post-Authorization Safety Studies
- Design and execute post-authorization studies that evaluate long-term safety, Risk factors, Benefit-risk in routine clinical use
PMCF & Registry-Based Evidence
- Support post-market clinical follow-up, Registries, Longitudinal evidence programs to track safety, Performance, Real-world outcomes over time
Drug Utilization & Treatment Pattern Studies
- Assess prescribing behavior, Adherence, persistence, Switching, Real-world product use across patient populations
Benefit-Risk & Special Population Surveillance
- Evaluate benefit-risk in broader and underrepresented populations, including elderly, pediatric, pregnancy, rare, and high-risk groups.
Aggregate Reporting & Lifecycle Evidence Support
- Support PSUR, DSUR, PBRER, and other lifecycle evidence needs with structured data, regulatory reporting inputs, and post-market study outputs.
Post-Market Study & Surveillance Lifecycle
A structured approach to safety monitoring, performance follow-up, regulatory reporting, and lifecycle evidence generation after launch.
Signal Detection
Identify emerging safety signals from pharmacovigilance and real-world data sources.
Signal Evaluation
Assess event patterns, frequency, severity, and subgroup differences to validate potential signals.
PASS / PMCF Study Design
Design post-authorization safety studies, follow-up programmes, and registries using fit-for-purpose methods.
Benefit-Risk Monitoring
Integrate safety, effectiveness, and real-world use data to monitor benefit-risk over time.
Regulatory Reporting
Support structured post-market reporting including PSUR, DSUR, PBRER, and related submissions.
Lifecycle Action & Evidence Support
Translate post-market findings into risk management actions, commitments, label support, and ongoing lifecycle decisions.
IQA Solutions for Post-Market Programs
Our post-market programs are strengthened by IQA’s solutions for surveillance, registry operations, data quality, coding, study design, and evidence workflow support across the product lifecycle.
We combine post-market expertise, methodological rigor, and technology-enabledexecution to deliver credible evidence for safety, compliance, and lifecycle decision-making.
Integrated Expertise
Safety, epidemiology, RWE, regulatory, and operational support in one team.
Methodological Rigor
Careful study design and analytics to address real-world safety research bias and complexity.
Technology-Enabled Delivery
IQA solutions support surveillance, registries, quality, coding, and evidence workflows.
Regulatory-Ready Outputs
Structured support for PASS, PMCF, reporting, and lifecycle evidence needs.
End-to-End Support
From signal detection to follow-up studies and post-market decision support.
Don't Wait for a Regulatory Signal
Tell us your product, your market and your surveillance gaps. We will design a proactive post-market surveillance programme that protects patients and defends your benefit-risk profile.