6 Part Time Physicians
11 Study Coordinator
40 Part Time Staff
Network of Specialists
Ca. 4.000 m²
80 overnight beds, 40 intensive care
Cantine (incl. special diets)
5 Call Center
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
10 Project Manager with scientific Education | 3 CTA | 1 Regulatory Affairs Manager | 2 Regulatory Start-up Coordinator
Preparation of Investigational Medicinal Product Dossier | organization of scientific advice meetings | Submission for Approval from Ethics Committee and Competent Authority
24/7 Availability | 3 Lab Technicians | 2 Data Specialists | 1 Support Staff
Lab Area of ca 100 m² | Roche Diagnostics Equipment
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
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
1 Statistician | 4 Data Programmer / 2 Data Analyst | Analysis of Study Data (SAS, WinNonlin) in ADaM Dataset Structure
3 Medical Writer (EMWA certified) | Preparation of Study Protocols | Investigator’s Brochure and clinical Study Reports in eCTD Format for Submission for Registration
1 Lead CRA & 4 Monitors in Europe | 1 Lead CRA & 4 Monitors in Lat. America
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
Partner for entire pharmaceutical industry from small Biotech to global Player.
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.