VIRTUAL TOUR

 

KEY FEATURES

The CRU comprises the following key features

  • 4.000 m² / 43.000 ft² area for assessments and hospitalization

  • Overnight facilities comprising of 100 beds for volunteer stay

  • Additional 40 beds in an intensive assessment area for:

    • Dosing

    • Blood sampling

    • Safety assessments

    • PD assessments

    • Telemetry equipment for 24 subjects

  • Full catering services including for special diets

  • Separate functional rooms for specialised assessments, e.g.

    • EEG

    • Ophthalmology

    • Women’s Health

    • Cardiovascular

    • Pulmonary

  • Dedicated blood sample work up rooms including a range of fridges, freezers and centrifuges including high-speed centrifuge

  • Back-up power generator

  • In-clinic safety laboratory with capability of measuring approximately 200 established safety parameters

  • Crash carts and emergency cases

  • Close proximity to 3 emergency units

  • In-house reconstitution capabilities

  • Recreation areas for volunteers

 

EXPERIENCE

Nuvisan Clinical Development is pleased to offer to the sponsor the complete spectrum of clinical pharmacology and exploratory studies. As a highly recognized service provider for International Pharma and Biopharma industries, we focus on early clinical drug development. Our clinical services include the following study types, and can be performed in healthy volunteers and in special patient populations:

  • First in man SAD / MAD and integrated packages

  • Studies with biologicals

  • Drug / Drug interaction studies

  • Food effect studies

  • Bioavailability and Bioequivalence Studies

  • Biosimilar studies

  • Studies on biomarkers, e.g. immunological parameters

  • Age and gender studies

  • Vaccination studies

  • Phase IIa, Proof of Concept studies special patient populations

 

Studies by type since January 2013

Type of studies 

Total No. from 1979             

Single dose

> 850

Multiple dose

  250

Total                  

> 1.230

 

 

EQUIPMENT & INSTRUMENTS

Our Clinical Research Unit is equipped with the following systems:

4 x ECG systems

24 x Telemetry ECG

5 x Oxygen saturation (SpO2) measurement system

1 x Ultracentrifuge

7 x Multi-Centrifuges

15 x Blood pressure monitors

13 x Syringe pumps

30 x Infusion pumps


Additional equipment can be sourced on request.

The use of each piece of equipment is guided by an internal SOP, describing calibration requirements in detail.

 

QUALITY STANDARDS

• GCP as defined in international and national Regulations: ICH-GCP, AMG, 
  GCP-VO, EU-Regulations

• A detailed internal audit program strengthens the clinical area to ensure 
  the rights, safety and well-being of volunteers and patients while 
  generating trial data

• Approval for handling narcotics

• QM Service for Clients / Customers: Trial specific audit planning, 
  performance and reporting

• FDA (frequent BIMO inspections)

• ANVISA (Brazil) Inspected and Approved

• ZAB, Regierung von Oberbayern (GCP, local Agency)

• BVMA Member

 

YOUR BENEFIT

• GCP, GLP and GMP services all under one roof

• A combination of medical and academic science with the professionalism 
  of the bio-pharmaceutical industry

• Study and/or clinical program design in close collaboration with the customer

• An interdisciplinary and experienced team of clinicians and scientists

• Allocation of a project team most appropriate for your project type and 
  therapeutic area

• Experienced project managers who will be your key contact for the duration 
  of your study

• A highly efficient, experienced, dedicated, well trained and medically 
  oriented team

 

OUR TEAM

Our clinic is divided into 3 main areas:

Clinical Conduct

• 6 experienced Investigators 
  (combined experience of approximately 80 years)

• 12 Experienced Study Coordinators

• 42 GCP trained and experienced medical staff

• 3 Laboratory Technicians

Clinical Operations

• 8 Specialised early development Project Managers

• 6 CTAs

• 3 Medical Writers

• 3 Regulatory/Study start-up Specialists

Data Science

• 1 Biostatistican

• 8 Dedicated statistical analysts with PK/PD expertise

 

Data Management

• 3 Data managers

• 2 Data coordinators

Contact

Business Development
Please send us an Email!

 

 

Dr. Sylvie Bruchmann
Vice President

James Dickinson
Global Head 
of Clinical Services

Dr. Florian Schwaak
Director 
Business Development