Ongoing medical data review

Beyond individual case management, we review safety data on a continuous and trend-based level — laboratory values, ECGs, vital signs and adverse events — to detect emerging signals early and protect the integrity of your dataset.

We can help you with:

• Medical and eligibility review, protocol deviation assessment
• Real-time medical support to investigational sites
• Ongoing review of safety data (labs, ECG, vital signs, AEs)
• Adverse event and SAE medical assessment — seriousness, causality, expectedness
• Dose-escalation decisions and Safety Review Committee / DSMB support
• Sentinel dosing oversight and stopping-rule assessment in first-in-human studies
• Medical coding (MedDRA, WHO Drug Dictionary)
• Medical input to data review meetings and protocol amendments