We specialize in full Phase I clinical trial services, offering innovative study concepts and ensuring meticulous long-term supervision.
With our regulatory expertise, we navigate the complex landscape of legal and ICH-GCP guidelines, guaranteeing a successful and timely study setup. From essential document preparation to site identification and regulatory submissions, we prioritize patient safety and regulatory compliance.
Our vigilant monitors, trained in various methods including risk-based monitoring, mitigate inherent safety risks in Phase I trials.
The Pharmacovigilance & Materiovigilance department plays a crucial role — they ensure swift information transfer and monitoring through bodies like the Data and Safety Monitoring Board (DSMB) and Safety Review Committee (SRC) and aim for the determination of the Maximum Tolerated Dose (MTD).
Our commitment ensures the trial progresses on time and within budget, yielding accurate safety signals.