Phase I Clinical Trials in Europe

Early development studies with regulatory precision and operational agility

Launching a Phase I clinical trial is one of the most critical milestones in the development of a new therapy. Early-stage studies require rigorous planning, regulatory expertise and carefully selected clinical sites to ensure reliable safety and pharmacokinetic data.

Novellas Healthcare supports biotech and pharmaceutical companies in the preparation and execution of Phase I clinical trials across Europe. Our teams combine regulatory knowledge, strong investigator networks and agile study management to help sponsors move from preclinical development to first-in-human studies with confidence.

Supporting sponsors from early development to first-in-human studies

Phase I studies represent the first step of clinical investigation in humans. These trials are designed to evaluate the safety profile, tolerability and pharmacokinetics of investigational therapies.

Because early clinical data is critical for future development decisions, Phase I trials must be conducted with exceptional scientific rigor and operational precision.

Novellas Healthcare supports sponsors in designing and executing early-phase clinical programs that meet regulatory expectations while ensuring efficient study execution.

Our Phase I clinical trial capabilities

Feasibility and site selection

Selecting the right sites is critical to ensure study quality and recruitment efficiency.
Our teams conduct detailed feasibility assessments and identify experienced Phase I investigators across Europe.

Regulatory and ethics submissions

Our regulatory specialists support the preparation and submission of clinical trial applications and ethics committee dossiers in accordance with European regulatory frameworks.

Study management and monitoring

Experienced clinical research associates and study managers ensure that Phase I trials are conducted in full compliance with regulatory standards and Good Clinical Practice guidelines.

Patient recruitment strategy

Depending on the study design, Phase I trials may involve healthy volunteers or specific patient populations.

Our teams support recruitment strategies adapted to the indication, ensuring efficient enrollment while maintaining strict safety monitoring.

From Phase I to later-stage development

Phase I trials represent the foundation of clinical development.
Reliable early data is essential to support the transition toward Phase II proof-of-concept studies and future regulatory milestones.

Novellas Healthcare supports sponsors not only during early-phase trials but also throughout the broader clinical development pathway.

Explore our capabilities in:

Phase II Clinical Trials

Phase III Clinical Trials

Phase IV and Real-World Studies

Therapeutic Areas of Expertise:

Oncology
Rare diseases
Infectious diseases
Neurology
Cardiovascular diseases
Specialty care

Preparing a clinical study in Europe?

Early development programs require the right clinical partner to ensure regulatory alignment, operational efficiency and scientific rigor.

If you are preparing a first-in-human study or evaluating European feasibility for your program, our clinical experts would be happy to discuss your project.