A Phase IV Clinical Trial, also known as Post-Marketing Surveillance or a Post-Approval Study, is conducted after a product has received regulatory approval. These trials are essential for monitoring the safety and performance of products, including drugs, biologics, and medical devices, in real-world settings.
The objectives of a Phase IV trial include:
- Collecting additional safety data, such as side effects and adverse events
- Understanding metabolism and mechanism of action (for drugs and biologics)
- Evaluating usability, durability, and performance (for medical devices)
- Supporting regulatory compliance through post-market clinical follow-up (PMCF) or other required studies for medical devices under FDA or EU MDR standards
Phase IV trials play a critical role in ensuring products meet ongoing regulatory requirements while providing real-world evidence of safety and effectiveness.
At dicentra, we specialize in:
- Protocol design tailored to drugs, biologics, or medical devices
- Trial management and coordination
- Data analysis and regulatory reporting
- Ensuring robust record-keeping and adherence to GCPs, FDA, and EU MDR standards
Whether your investigational product is a pharmaceutical or a medical device, dicentra’s expertise ensures your Phase IV trial is conducted efficiently, meets all regulatory requirements, and provides the real-world data you need.