First-in-human (FIH), safety & immunogenicity, SAD/MAD, and dose-finding studies
INFECTA is a global leader in first-in-human (FIH) clinical trials for more than ten years. We specialize in early-stage studies that test new drugs and vaccines in healthy volunteers, focusing on safety, tolerability, and immune response. Using our unique single ascending dose and multiple ascending dose (SAD/MAD) designs with preliminary efficacy readouts, we go beyond safety assessment and no-observed-adverse-effect level (NOAEL) and pharmacokinetics to effective dosing and minimum anticipated biological effect level (MABEL) determination for later trial phases. Our expertise spans FIH trials with viral vector vaccines, live attenuated vaccines, GMOs, biologicals, antiviral, antibacterial and antiparasitic agents, which are preferably tested with controlled infection models. We provide the ideal environment to combine endpoints in adaptive clinical trials to maximize your scientific output.
Participant recruitment & retention
Our ultra-modern facility is located in the Netherlands, at the heart of the Leiden Bio Science Park. INFECTA brings more than 30 years of experience in clinical research for both inpatient and outpatient studies. Over the years, we have built a prestigious reputation as a reliable and trusted partner in early-phase clinical trials. Our healthy volunteer recruitment process is supported by a large and diverse network, which allows us to achieve timely and effective enrollment. Afterwards, volunteers consistently report positive experiences, emphasizing the professionalism, care, and clear communication they receive throughout the study. All research is conducted according to the highest ethical and safety standards, with full respect for the well-being and rights of our participants. This participant-centered approach not only strengthens recruitment but also promotes long-term retention, leading to successful study completion with high-quality data.
Study design and protocol development
At INFECTA, we guide sponsors through every step of study design and protocol development. Working with medical experts from all Dutch UMCs, as well as a broad academic network, study plans are created that are not only reliable and compliant with regulatory requirements, but also tailored to project needs whilst engaging with key opinion leaders in the field. We maintain open dialogue with sponsors, listening to their objectives while proposing the best solutions from both a scientific and financial perspective. Complex, multi-part studies are supported by our experienced drug development consultants. With a full-service approach, we provide seamless coordination from design to execution, combining scientific quality, regulatory compliance, and operational efficiency.
Clinical conduct in accordance with ICH-GCP
We are committed to providing the best quality data, at the highest regulatory standards and work with the best partners globally. To accomplish this, we are highly critical of the quality of the work we provide, giving us a strong reputation in the field. By operating in an open transparent manner, engaging our clients and ensuring our regulators maintain scientific integrity, we strive to be a trustworthy partner.
Data management & biostatistics
At INFECTA, data integrity and traceability are at the core of every study. Each project begins with a data management plan, developed with the sponsor and following ICH-GCP guidelines, which defines procedures to maintain complete and accurate data. Afterwards, a study-specific database is created and rigorously validated before data collection begins. During the study, data collection is closely monitored, reconciled, and fully documented in an audit trail. Wherever necessary, medical coding, including adverse events, will be applied systematically. Before database lock, all data is reviewed, reconciled, and verified to maintain accuracy and completeness. Our in-house statisticians can then generate reports and analyze variables according to study requirements. All processes are conducted in-house, with no offshore outsourcing, ensuring the integrity, security, and full traceability of the data from collection through analysis.