The Anatomy of a Clinical Trial

The Stages of a Medical Device Clinical Trial

1. Start-Up

Learn about the Start-Up Services and Preliminary Stage of a Medical Device Clinical Trial from our 'Choosing a CRO' page.
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2. Early Feasibility Study (EFS)

Early Feasibility Study (EFS) is used to study the safety and use of the device. At this point it is not used on patients, engineering and changes to the product can still be made. Focus is on safety, achieving the intended use, defining therapeutic parameters, and identifying failures or issues.

CRO SERVICES USED

Clinical Affairs

Data Management

Engineering

Technical Writing

Regulatory Management

Quality Management

4. Feasibility

Feasibility studies (also known as Pilot studies) test the safety and efficacy in a small group of people. This study will see if the device performs the action it is intended to. This will test performance and feasibility before the Pivotal study.

CRO Services Used

Clinical Affairs

Data Management

Biostatistics

Engineering

Technical Writing

Regulatory Management

Quality Management

4. Pivotal

Pivotal study is used to demonstrate the effectiveness across a variety of populations and against designated endpoints. This lasts the longest and is where you obtain all the data and insights that will be used to receive FDA and IRB approval.

CRO Services Used

Clinical Affairs

Data Management

Biostatistics

Technical Writing

Regulatory Management

Quality Management

5. Did the trial pass? Yes or No.

The next two stages for a medical device clinical trial depend on the success of the trial. If trials are successful they can end in a PMA (Pre-market Approval) or post-market study. If a trial does not meet the FDA’s standards it will undergoe a futility study to analyze what went wrong.

No?
Futility Study

Yes?
PMA or Post-Market Study