SITE GAUTING

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THE EXPERT SITE FOR COMPLEX STUDIES AND CLINICAL TRIALS IN PATIENTS

Excellence center for the planning, conduct and evaluation of clinical trials with complex endpoints in healthy subjects or patients throughout all phases.
A focus and special expertise exists in conducting clinical trials in the respiratory therapeutic area. The site has a database of patients which are difficult to recruit such as Cystic Fibrosis patients. Patients can be hospitalized in a personal atmosphere and individually cared for. Clinical multi-center studies can also be organized.
The Gauting site also performs specialized studies with medical devices such a flow-profile investigations for inhaler devices.

Infrastructure

Headcount: 25 employees
Bed capacity: 24 bed overnight stay capacity and 6 beds for intensive assessments

Inspections & Authorizations

The Gauting site has been successfully inspected by the German Regulatory Agency BfArM and local authority. Routine client audits are carried out frequently.

History

In 2019, the formerly independent CRO Inamed (also known as “The Respiratory CRO”) joined the NUVISAN group, allowing for a portfolio expansion to phase II patient studies.

Working Fields and Specialties

In-house clinical pharmacology unit ranging from phase I studies (First-in-man studies, safety, pharmacokinetic and pharmacodynamic studies in healthy subjects or patients), phase II studies (clinical efficacy studies in patients), clinical investigations with medical devices (e.g., inhalers), and related clinical study services such as project management, medical writing, data management, biostatistical evaluation, quality assurance, regulatory affairs and consulting.

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Our Services & Solutions along
the Drug Development Value Chain

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Discovery

PRECLINICAL

Clinical Phase I

Clinical Phase II

Overall Services

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management