With 40 years of experience in clinical solutions, NUVISAN offers a comprehensive portfolio of services covering the full spectrum of clinical development. Our team of experts has extensive experience in designing and conducting early clinical trials for various objectives. In our large study clinic in Neu-Ulm, we conduct all types of phase-I studies, including First-in-Man (FIM) studies, pharmacokinetic (PK) studies, safety studies, and pharmacodynamic (PD) studies in healthy subjects. We have a proven track record of conducting complex studies, including those involving biologics, biosimilars, and novel modalities.
Our clinic in Neu-Ulm is also equipped to host early phase-II clinical trials in patients, often referred to as “phase IIa” trials. These trials are usually highly controlled and complex, requiring the hospitalization of a defined target volunteer population over a limited period (for example, to investigate pharmacokinetic profiles, efficacy measurements, or special biomarkers).
NUVISAN offers a full range of clinical trial services, including clinical trial management, data management, biostatistics, medical writing, and clinical monitoring. In addition to clinical trial services, NUVISAN also provides Clinical & Regulatory Consulting services to help our clients navigate the complex regulatory landscape. Our regulatory experts have a deep understanding of European regulatory requirements and can provide guidance and support throughout the drug development process.
