Real-World Evidence & Registries

IN ONE SIMPLE SENTENCE

Collecting and analyzing real-world device-use data to assess performance, safety and outcomes in routine practice.

What is this service?

After market entry, substantial real-world information is generated by hospitals, users and patient follow-up. When collected in a structured way, it can become valuable clinical evidence.

GOAL

Understand device performance in larger populations, more realistic settings and longer time periods than initial studies usually allow.

What can MICT do here?

Design registries, define variables, create the data dictionary, control data quality, perform longitudinal analyses and produce RWE reports.

TYPICAL INPUTS

What we usually need to start

Research or surveillance question
Real-world data sources
Population definition
Device identifier
Clinical variables and outcomes

TYPICAL OUTPUTS

What this stage can deliver

Registry protocol
Data dictionary
Longitudinal dataset
RWE analysis
Real-world findings report
Inputs to PMCF, CER and PMS

Important terms in plain language

Real-World Data (RWD)

Data generated during routine care or real-world device use.

Real-World Evidence (RWE)

Evidence generated by analyzing real-world data.

Registry

A structured system for recording and following a defined population.

Longitudinal Data

Data collected from the same person or device at multiple time points.

Data Dictionary

A precise definition of each data field, its type and how it should be recorded.

SIMPLE EXAMPLE — BLOOD PRESSURE MONITOR

A blood-pressure-monitor registry can follow thousands of users across hospitals and show how the device performs in older adults, people with diabetes or users with different arm sizes.

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