Expert medical review - monitoring for healthy projects
In order to ensure quality, validity and integrity of data leading to approval of new drugs and devices and the protection of patients involved in clinical development, medical review efforts are of utmost importance. PPH plus medical advisors provide competent and efficient medical review of:
- Essential study documents
- Patient and visit data (medical monitoring)
- Laboratory/ECG data
- Protocol deviations
- Coded adverse events, medical history, concomitant medications
- Regulatory documents
- Marketing materials
- Publications
