Nuvisan offers early-stage services to pharma, biotech and medtech companies from a single location in Germany.
From first-in-human and regulatory studies within our clinical pharmacology unit (CPU) to multicentre proof-of-concept studies, we provide integrated early-phase clinical services; including conduct, laboratory and trial supply services.
Nuvisan clinical services offer significant advantages:
Nuvisan can help guide the adoption of development strategies for early clinical steps, from pre-clinical translation to achieving POC in patients as early as possible.
We have successfully implemented strategies for FIH trial submissions, leading or supporting the clinical study protocol (CSP) design process to meet regulatory objectives regarding primary and secondary endpoints.
Further strategies such as combining SAD and MAD studies, for example, require articulating clear rules in the umbrella protocol for dose escalation and stopping criteria.
Nuvisan also supports the organisation of scientific advice procedures and dialogue with regulatory agencies.
Nuvisan’s fully automated Clinical Pharmacology Unit (CPU) in Neu-Ulm, Germany conducts various types of FIH trials, including combined protocols (e.g. SAD / MAD), PK/PD, POC and regulatory studies such as DDI, TQT, Relative BA, BE, biosimilarity and FE.
We also support studies in special populations and patients requiring partial hospitalisation, with complex endpoints as well as additional PD markers and biomarkers.
Our board-certified physicians, clinical teams and external collaborators help ensure strict adherence to regulations and protocols, implementing study-specific assessments from simple to complex.
At Nuvisan, we help ensure efficient and timely participant onboarding with a database of >24,000 active participants and >100,000 newsletter subscribers.
Our teams dedicated to volunteer identification and social media management define subject engagement strategies and support participants throughout the process.
Our database is optimised for accurate pre-identification, and our approach helps keep client projects aligned with planned budgets.
Nuvisan´s clinical pharmacology unit (CPU) in Germany is equipped with an electronic source-data capturing system (ClinSpark eSource) where data are available to Nuvisan staff, clients and CRAs, as soon as they are collected.
eSource offers simplicity and accessibility to study data through:
Exposure is an important criterion for dose escalation and decision making. Having clinical safety, bioanalysis and immunoassay labs in the same building as our CPU helps reduce turnaround time for safety laboratory parameters, PK results of the preceding cohort (24–48 hours), and enables online evaluation of safety and PD parameters (eg pro-inflammatory cytokines or biomarkers).
Moreover, early investigation of human metabolites and differences in the metabolic profiles compared to animal species used for toxicological testing are also key to assessing safety and efficacy of your product. Proactively performing this investigation with Nuvisan’s laboratory in Grafing in phase 1 helps detect any human-specific or disproportionate metabolites early and mitigate the risk of late-stage delays due to unknown metabolite liabilities.
Nuvisan’s clinical laboratory integrates its LIMS with our eSource system through a validated HL7 interface, enabling fast and secure data transfer. This connectivity ensures rapid turnaround for key safety parameters and supports streamlined workflows for efficient project delivery.
Learn MoreNuvisan’s GLP- and ANVISA-certified facility delivers comprehensive bioanalytical solutions for small and large molecules. Our expertise covers complex compounds, including oligonucleotides, peptides, proteins, ADCs, biosimilars and radiolabeled molecules, supported by advanced methods for challenging sample types.
Learn MoreBiomarker analysis provides valuable insights for early-stage development, supporting informed decision-making and efficient planning. Nuvisan offers development and validation of regulated bioanalytical methods for biomarker determination, leveraging expertise to address challenges such as matrix selection, sample preparation and multi-marker monitoring.
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Our clinical pharmacology unit conducts early phase clinical studies for our clients for over 40 years.
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We provide clinical development support for your multicentre phase 1-2 studies.
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Discover how our comprehensive clinical services can support your efforts.
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