In Phase II studies, capturing a swift and reliable signal for drug efficacy is our focal point, accompanied by vigilant monitoring of safety signals.
Our dedicated monitoring activities focus on optimizing dosing for investigational drugs, emphasizing shortterm side effects and safety risks.
With a seasoned Project Management team, we ensure a structured and streamlined approach, coordinating all trial steps with a robust risk management strategy.
Leveraging years of collaboration with investigators, our Operations department selects suitable sites, supported by comprehensive training and quality control for efficient study execution.
Our ongoing risk-based approach guarantees compliance with ICH-GCP and local laws.
Clear and concise protocols and presentation of study results are crafted by our skilled Medical Writers, ensuring consistency with diverse audiences.
Our Statisticians prioritize validated statistical programming and the development of analysis databases in accordance with CDISC standards. As Phase II trials conclude, they meticulously prepare result analyses for the clinical study report, providing robust support to medical researchers in publishing their findings and scientific presentations in collaboration with the Sponsor.
