Post-Authorization Safety Studies

Track every PASS from protocol to final report, and use the results to prove your aRMMs are working, with compliance and outcomes evidence in one view.

Request a Demo

Study Milestones

Know where every study stands, from protocol to final report.

Post-authorization safety studies continue the safety work after a medicine reaches the market: characterizing known and potential risks, confirming the safety profile in real-world use, and assessing whether additional risk minimization measures (aRMMs) are effective. Whether a study is required by a health authority, such as an FDA postmarketing requirement or an imposed EU PASS, or committed to voluntarily in a risk management plan, each one runs for years and answers to fixed regulatory dates.

In Orbit, each of those dates is a tracked task with an owner, and the protocol, registration record, and final report attach to the same commitment. A long-running study stays visible between reports instead of resurfacing only when it is overdue.

Protocol and PRAC endorsement

Track protocol submission and, for imposed non-interventional studies, the PRAC assessment of the protocol.

Study registration

Record registration in the HMA-EMA Catalogue of real-world data studies, which replaced the EU PAS Register.

Final study report

Count down to the final report, due within 12 months of the end of data collection.

Regulatory follow-up

Carry the outcome into the next step, such as a product information change or an RMP update.

aRMM Effectiveness Assessment

Prove the aRMM works, not just that it was delivered.

Regulators ask two questions about every additional risk minimization measure. Was it implemented as agreed, in every market, for every audience? And did it change what people know, what they do, and what happens to patients? The first is compliance. The second is what the EMA calls effectiveness evaluation, and a PASS is often how it gets answered.

That evidence is now expected on a schedule. Since February 2026, PSURs for EU products must include updates on how risk minimization measures were implemented and how effective they were (Implementing Regulation (EU) 2025/1466). In the US, the FDA asks the same of REMS assessments, and Orbit tracks both in one place.

1. Compliance

Did the work get done?

Time to implement, from core aRMM issued to local approval and first dissemination
Implementation status in every market, including acknowledgment of each new version
Local variations from the core aRMM, and why
Roll-out to healthcare professionals, patients, and pharmacists against target numbers

2. Outcomes

Is it working?

GVP Module XVI looks at three layers:

Dissemination and knowledge: Did the right people receive it, and do they understand the risk and the action to take?
Behavior: Are people doing what the aRMM intends, such as testing before treatment or avoiding contraindicated use?
Health outcomes: Did the occurrence or severity of the adverse reaction go down?

The guidance also asks teams to watch for unintended effects, such as patients stopping a medicine that is still right for them.

Compliance without outcomes shows you were busy. Outcomes without compliance cannot tell you why a measure failed: was the material wrong, or did it never arrive?

Close the loop on every evaluation

GVP Module XVI describes risk minimization as an iterative cycle: evaluate, decide, amend, and evaluate again. In Orbit, that cycle is how the platform already works.

1 Success indicators agreed in the RMP before the data comes in
2 PASS and survey results recorded against those indicators, next to the compliance data for the same aRMM
3 When the evidence points to a change, the core aRMM is updated and Orbit creates the new local versions
4 Recurring tasks re-measure at the timepoints your RMP sets, so you can see whether the change moved the result

Why It Matters

Studies run late, and too many end without an answer.

4 in 10

PASS evaluating risk minimization that PRAC assessed between 2016 and 2021 reached no conclusion on effectiveness.

Grupstra et al., Clinical Pharmacology and Therapeutics, 2023

47%

of EU centrally authorized medicines approved with aRMMs from 2012 to 2021 had an evaluation study planned.

Essink et al., Drug Safety, 2023

4 in 5

evaluation studies that should have finished were more than three months late against their planned date.

Essink et al., Drug Safety, 2023

An inconclusive study leaves the question open and the aRMM in place, unproven. Tracking every milestone against its planned date shows a slipping study while there is still time to act.

Results are also hard to read without knowing when and where each measure was in place. Orbit keeps the approval, dissemination, and acknowledgment dates for each local version, so evaluators can line study results up with what was actually implemented.