IN ONE SIMPLE SENTENCE
Designing and running a human clinical study to assess device safety and performance.
What is this service?
When human data are needed to support clinical safety or performance, a clinical investigation is designed and conducted under a defined protocol at suitable sites.
GOAL
Answer a clear clinical question, such as whether the device performs with acceptable accuracy in the target population.
What can MICT do here?
Develop the protocol/CIP, define eligibility criteria, select sites, plan operations, train study teams, monitor the study and coordinate data collection.
TYPICAL INPUTS
What we usually need to start
- Primary study question
- Device specifications and intended purpose
- Preclinical evidence
- Target population
- Risks and planned endpoints
TYPICAL OUTPUTS
What this stage can deliver
- CIP / protocol
- Data-collection forms
- Site selection and activation plan
- Monitoring reports
- Analysis-ready clinical data
- End-of-study report
Important terms in plain language
Clinical Investigation
A planned human study to assess medical-device safety or performance.
Protocol / CIP
The main study document describing why and how the study is conducted, who is enrolled and what is measured.
Inclusion/Exclusion Criteria
Rules that determine who may or may not enter the study.
Endpoint
A predefined outcome used to evaluate the study, such as accuracy or an adverse event.
Site
The hospital, clinic or research center where the study is conducted.
CRA / Monitor
A clinical research associate or monitor who checks study conduct against the protocol and requirements.
SIMPLE EXAMPLE — BLOOD PRESSURE MONITOR
For a blood-pressure monitor, readings can be compared with a reference method at multiple time points and measurement error can be assessed across age groups.