Services

Clinical

The modern Phase I Unit set-up
in Neu-Ulm and Gauting near Munich

Staff

6 Physicians

6 Part Time Physicians

11 Study Coordinator

40 Part Time Staff

Network of Specialists

Facilities

Ca. 4.000 m²

80 overnight beds, 40 intensive care

Functional rooms

Cantine (incl. special diets)

Laminar flow

Capacities

4 Recruiter

5 Call Center

Services

4 Decades of Experience in PK/PD Trials

Broad Experience with NCE, NBE and Biosimilars

Possibility for combed Study Designs e.g. SAD, MAD, FDI, DDI, Patient PK/PD

Project Management

Staff:
10 Project Manager with scientific Education | 3 CTA | 1 Regulatory Affairs Manager | 2 Regulatory Start-up Coordinator

Regulatory Affairs:
Preparation of Investigational Medicinal Product Dossier | organization of scientific advice meetings | Submission for Approval from Ethics Committee and Competent Authority

Safety Laboratory

Staff:
24/7 Availability | 3 Lab Technicians | 2 Data Specialists | 1 Support Staff

Facilities:
Lab Area of ca 100 m² | Roche Diagnostics Equipment

In-House Trials:
Door to Door with CPU | Turnaround 4 to 6 Hours | Continuous Safety Assessments

Central Lab Sample Logistics and Documentation | Samples analyzed on the Day of Receipt | Data Export in Client specific Formats

Backend Services

Data Management:
6 Data Manager / 2 Data Coordinator | Preparation of Paper CRF or eCRF according to CDASH | Setup and Validation of Database (Clintrial | Inform) / Data Cleaning | Data Provision in SDTM Data file structure

Biostatistics:
1 Statistician | 4 Data Programmer / 2 Data Analyst | Analysis of Study Data (SAS, WinNonlin) in ADaM Dataset Structure

Medical Writing:
3 Medical Writer (EMWA certified) | Preparation of Study Protocols | Investigator’s Brochure and clinical Study Reports in eCTD Format for Submission for Registration

Monitoring:
1 Lead CRA & 4 Monitors in Europe | 1 Lead CRA & 4 Monitors in Lat. America

WHY WORKING WITH NUVISAN?

One of the first Early Phase CROs in Europe (1979)

Full Service from Consultation to Reporting | Data Management | Statistic & Monitoring Bedside Monitoring Software

30 Projects conducted in 2018 | 85 %Repeat Business

OUR CLIENTS IN THIS SECTION

Partner for entire pharmaceutical industry from small Biotech to global Player.

Summary

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.

CORRESPONDING SITES

Neu-Ulm / Germany