Nuvisan’s Clinical Pharmacology Unit (CPU) (Neu-Ulm, Germany) has conducted the full breadth of early phase trials in healthy volunteers, special populations and patients for our valued clients and for over 40 years.
Trial complexities
Our on-site medical and operational experts conduct thorough feasibility assessments for each trial, collaborating closely with clients, partners, external specialists and sites to enable successful outcomes, even with the most complex trial requirements.
Simple to complex early phase trial solutions
Our CPU performs the complete spectrum of early exploratory and regulatory clinical studies including, but not limited to:
First-in-human (FIH), single ascending dose (SAD)/ multiple ascending dose (MAD) and combined protocols for both new chemical entities and new biological entities
Phase 2a proof of concept (PoC) studies
Drug/drug interaction (DDI) studies
Food effect (FE) studies
Bioavailability (BA) and bioequivalence (BE) studies
Pharmacokinetic (PK)/pharmacodynamic (PD) studies
Studies in special populations (eg postmenopausal women)
Age and gender studies
PK studies in patient populations.
Studies are performed within our CPU – which has 40 high-monitoring beds and an additional 60 overnight beds – by our highly experienced in-house clinical staff, who always strive to meet the highest quality standards, as proven by our considerable number of successful inspections and audits by international authorities.
Our specialist recruitment team delivers fast, targeted enrolment for studies involving healthy volunteers, special populations and patients. Through our highly engaged newsletter community of more than 100,000 subscribers, we reach the right participants quickly, efficiently and reliably.
Our clinical pharmacology unit provides a high-quality early phase environment, combining state-of-the-art infrastructure with strong medical expertise. With 40 intensive care beds, 60 overnight beds, an automated eSource clinic platform (ClinSpark) and direct access to a clinical safety laboratory, we support efficient, high-quality study delivery.
Our team includes board-certified clinical pharmacology physicians, emergency specialists and external experts where needed. We conduct all studies in full compliance with ICH GCP and bring extensive experience supporting inspections by BfArM, EMA, FDA, WHO and ANVISA. This approach supports consistent, high-quality assessments and strong participant safety.