Planning and preparing your clinical trial

Analysing data

Presenting trial results

Systems and software in use

We serve as consultants for all biometrical aspects of clinical trials from phase I-IV and NIS . With a median experience of two decades in clinical research and a broad therapeutic expertise, our biostatisticians provide their professional services for 

• clinical trial design
• sample size estimation
• statistical analysis and 
• statistical reporting

Planning and preparing your clinical trial

• communication with regulatory authorities 
• elaboration of best clinical trial design 
• sample size estimation 
• development of statistical parts of the protocol 
• protocol and CRF review 
• development of randomisation plan 
• review of data management plan 
• development of statistical analysis plan 

Analysing data

• design, programming, and quality control of data displays 
• confirmatory analysis 
• exploratory analysis 
• interim analysis and sample size adaptation 
• meta analysis and data mining 
• integrated summary of safety (ISS) 
• integrated summary of efficacy (ISE) 
• common technical document (CTD)

Presenting clinical trial results

• development of statistical reports 
• development of integrated clinical study report 
• publications 
• adequate presentation of clinical trial results

Software in use

• SAS® 9.2 (Base, Stat, Graph, Access to ODBC, Enterprise Guide)
• nQuery®
• Addplan®
• EquivTestTM
• Comprehensive Meta Analysis