Numerous effective supported clinical studies

ClinStat realized considerable number of successful studies

Events - News

Upcoming events....

Home

Legal Notice

Sitemap

How to find us

Read more >>

Read more >>

ClinStat - Data Management

Data Management

Superb data management is an important factor in clinical research

Read more >>

ClinStat - Statistical Programming

Stat. Programming

Comprehensive

Services for any phase of drug development

Read more >>

ClinStat - Medical Writing

Medical Writing

Planning of studies, accurate reporting and approval process

Read more >>

Clinstat - HEOR/Market Access

HEOR/Market Access

compiling data in the right way, at the right time

Read more >>

Biostatistics

ClinStat offers the complete range of statistical services

Read more >>

ClinStat - Statistical Programming

ClinStat GmbH 2017
© Copyright - All rights reserved

ClinStat GmbH

Phone:  
+49 2234 9919911

Email:           info@clinstat.eu  
Homepage:  www.clinstat.eu

Max-Planck-Str. 22a
50858 Cologne/Germany


Institute for clinical
research and statistics



Home

Legal Notice

Sitemap

Contact

Your data. Our passion.

ClinStat

ClinStat - Data Management

Data Management

Superb data management is an important factor in clinical research

Read more >>

ClinStat - Statistical Programming

Stat. Programming

Comprehensive

Services for any phase of drug development

Read more >>

ClinStat - Medical Writing

Medical Writing

Planning of studies, accurate reporting and approval process

Read more >>

Clinstat - HEOR/Market Access

HEOR/Market Access

compiling data in the right way, at the right time

Read more >>

Biostatistics

ClinStat offers the complete range of statistical services

Read more >>

ClinStat - Statistical Programming

Biostatistics

Data Management
Biostatistics
Statistical Programming
HEOR/Market Access
Medical Writing

Biostatistics



ClinStat offers the complete range of statistical services. Our industry-experienced biostatisticians in collaboration with our clinical SAS programmers deliver high-quality products. Biostatistician at ClinStat with their expertise in special indications and profound understanding of ICH-GCP guidelines and regulatory requirements insure best quality work over all stages of clinical development.

Our services include:

       Highly experienced, competent employees

       Statistical planning of clinical trials with sample size calculation in accordance
          with ICH E9 and other ICH, CPMP or FDA guidelines

       Providing random codes (e.g. in form of randomization lists)

       Statistical Analysis Plan including production of shells for TLFs (tables, listings, figures)

       Conduction of statistical analysis

       Missing data analysis

       Validation of analysis data sets (e.g. ADaM) and programming for TLFs

       Support of CDISC SDTM and ADaM standards

       Participation in DSMBs

       Exploratory analyses for publications and marketing

       Contribution/production of biometrical parts of integrated reports

       Interim analyses using adaptive designs

       Analysis of data for safety monitoring boards (DSMBs)

       Independent Biostatistician as DSMB member

       ISS/ISE analysis or expert reports

       Pre-clinical studies

       Meta-analyses

       Pharmaco-economic analyses

       Public health, health services research and health economics analyses

       Epidemiological or medical device studies

       Non-prescription drugs/products analyses

       Statistical support for AMNOG dossiers in Germany

       Presentation of data to regulatory agencies


Statistical software

       SAS (statistical programming and analysis)

       R (statistical programming and analysis)

       StatXact (exact statistical methods)

       nQuery (sample size calculation)


For new patented pharmaceuticals, price negociation with payers (GKV-SV) based on early benefit assesment

Read more >>

Market Access

TLF programming accurate, clear and corresponding to

ICH E3 guidelines

Read more >>

Statistical
Programming

Meeting the required international standards and assuring accurate data

Read more >>

Data Management

High quality services for your business