Accuracy & Compliance in a Phase I/II Trial Involving Preterm Neonates
Accuracy & Compliance in a Phase I/II Trial Involving Preterm Neonates
2 PagesCASE STUDY Study Overview: Pharm-Olam was contracted to provide clinical research services on a Phase I/II pediatric Respiratory Distress Syndrome study involving neonates with a gestational age between 27 and 33 weeks. This first-in-human study required a single intratracheal administration within 24 to 48 hours of birth. Study Details: • Phase I/II • Patients: 40 • Sites: 12 sites in 3 countries—Great Britain, Germany, and Czech Republic • Services Pr ovided: • Regulatory • Monitoring • Project Management • Pharmacovigilance • Data Management • Biostatistics • Medical Writing • Medical Monitoring • Management of Data and Safety Monitoring Board (DSMB), required for each cohort within 48 hours of birth • Management of Safety Monitoring Board (SMB) a
