Clinical Sciences & Analytics

Neu-Ulm

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We have a proud heritage of providing comprehensive services for clinical studies from first-in-human (FIH) through proof-of-concept (PoC). This includes everything from clinical study design and consulting, global project management and regulatory support, medical and safety monitoring to data management, biostatistics, clinical pharmacokinetic/pharmacodynamic (PK/PD) and medical writing services.

We deliver these services through our Early Phase Clinical Units (EPCUs) comprising two clinical pharmacology facilities Germany (Neu-Ulm and Gauting).

Our EPCUs comprise a total of 150 beds, giving us the capacity to schedule studies within required timeframes. Within our EPCUs we have state-of-art laboratory and pharmacy facilities. Our EPCU in Gauting has a long tracking record of successfully managed studies in the respiratory research. This comprises inhalation studies in healthy subjects, allergen challenge studies in predisposed patients as well as our capability to enroll patients with chronic asthma, COPD, Cystic Fibrosis and other indications.

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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