Clinical Trials
We are your expert partner for navigating the complexities of clinical trials. Our team provides specialized support for the development of innovative therapies, including medicinal products, medical devices, small molecules, biologics, ATMPs, and gene therapies. We deliver strategic guidance and operational excellence across the entire clinical trial lifecycle to ensure regulatory compliance.
Our Technical Expertise
We bring a, science-based approach to every aspect of your clinical trial.
Our services are designed to meet the strict requirements of local and international health authorities, guaranteeing data integrity and operational efficiency.
Our Services Include:
Protocol Development & Design:
We specialize in crafting scientifically sound clinical trial protocols that align with ICH-GCP guidelines and NDA (National Drug Authority) regulations.
Site Selection & Management:
We identify and qualify high-performing clinical trial sites with proven patient populations and experienced investigators.
Patient Recruitment & Retention:
Our strategy involves a data-driven approach to patient recruitment, utilizing local insights to identify eligible patients quickly.
Data Management & Analysis:
We employ advanced data management systems (EDC) to ensure the precise and accurate collection of clinical trial data
Regulatory Affairs:
We serve as your primary point of contact with health authorities. We handle all regulatory submissions, including IND applications and clinical trial authorizations.