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Clinical services / phase 1-2

Accelerate the development of your investigational drug by partnering with Nuvisan to efficiently reach your Go/No-Go decision, empowering key strategic choices and confidently advancing your clinical development plan.  
 
Specialising in phase 1–2 clinical trials and based in Neu-Ulm, Germany, our comprehensive, all-under-one-roof clinical trial services include trials conducted at our state-of-the-art clinical pharmacology unit (CPU) as well as clinical trial management (for both our CPU and multicentre trials),  medical and regulatory consulting, clinical study protocol and report (CSP/CSR) writing, project management, clinical and medical monitoring, data management, biostatistics and regulatory support.
Patient room with white interior for clinical trials

Clinical pharmacology unit

First-in-human (FIH) or phase 1 studies mark the critical starting point of your clinical development journey. At Nuvisan, this is where we demonstrate the full range of our clinical expertise, guiding and supporting you all the way to proof-of concept (PoC).

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Doctor consulting with a patient about clinical trial recruitment

Multicentre patient studies

A pivotal step in early clinical development is the PoC study in patients, and it is crucial to meet this milestone as early as possible. Nuvisan can support sponsors to identify and qualify the most relevant sites for each project, ensuring close collaboration with each site to achieve successful outcomes.

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Clinical Operations team discussing clinical trial related planning

Clinical operations

When a sponsor entrusts a project to Nuvisan, our project managers facilitate continuous communication between the project team, our sponsors and our clinical research associates at the study sites, as effective communication and comprehensive oversight are essential for a study's success.

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Management, cleaning, and validation of clinical databases during a clinical trial

Data management

Nuvisan has long-established experience in clinical data management, and our team of highly qualified professionals follows industry best practices, supporting you to meet key trial milestones.

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Biostatistician analyzing data on a laptop screen in a modern office setting

Biostatistics

From the earliest stages of clinical development planning, and at every key point of your clinical development program, our biostatisticians provide expert guidance to optimise the statistical design and analysis of studies in a broad spectrum of development phases and indications.

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Colorful pills capsules on blue background

Drug safety

Nuvisan helps ensure compliance with good clinical practice (GCP) guidelines and country-specific regulations by providing continuous evaluation and reporting of safety concerns throughout early clinical trials. These efforts aim to assist sponsors in improving risk-benefit assessments at every stage of early drug development.

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Strategic decision making for clinical trials and clinical development programs

Clinical development consulting

Nuvisan can support in adapting development strategies for the pivotal early steps in clinical development to support you with translation from pre-clinical to clinical and reaching PoC in patients as early as possible.

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A clinical sample being prepared for analysis in a safety laboratory

Clinical laboratory

Co-located with our CPU, our clinical safety lab offers a comprehensive range of analyses using CE-certified tests and sample barcoding to help ensure the reliability and accuracy of your safety data.

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