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ClinStat - Data Management

Data Management

Superb data management is an important factor in clinical research

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ClinStat - Statistical Programming

Stat. Programming

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Services for any phase of drug development

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ClinStat - Medical Writing

Medical Writing

Planning of studies, accurate reporting and approval process

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Clinstat - HEOR/Market Access

HEOR/Market Access

compiling data in the right way, at the right time

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Biostatistics

ClinStat offers the complete range of statistical services

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ClinStat - Statistical Programming

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ClinStat GmbH

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+49 2234 9919911

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

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


Institute for clinical
research and statistics



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ClinStat

Data Management

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Statistical reduction of complexity

Creating the documentation that regulatory agencies require in the approval process for drugs

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Medical Writing

Data Management
Biostatistics
Statistical Programming
HEOR/Market Access
Medical Writing
As a client-oriented institute for clinical research and statistics, ClinStat offers our clients tailored solutions in nearly all important therapeutic areas. Our highly qualified data managers adhere strictly to international and national quality standards from the beginning of the project until the end.
Superb data management is an important factor in clinical research. With the planning, creation, validation and documentation of the study database, we ensure that complete, correct and reliable electronic data collection is possible. To ensure integrity and validity, we implement quality assurance and quality control measures.

Our services cover:

      Highly experienced, competent employees

       Close collaboration with all involved
       Creation of the Data Management Manual comprised from the Data Management Plan and           Data Management Report
       Client-specific database design and/or according to the recommendations of the Clinical Data           Interchange Standards Consortium (CDISC):
       Application of the Study Data Tabulation Model (SDTM), which groups acquired data due to the           fact that technically-related information of a definable topic area is formed as entities in           domains.
       Use of the data standard, Analysis Data Model (ADaM), which is a model for analysis data and           its metadata. In the process, the data structures become so specified that a statistical           analysis is possible without further data transformation steps
       CRF design
       CRF and query management
       Full range of CRF printing and configuration possibilities
       Complete printing administration and CRF shipment and tracking
       CRF annotation, definition of data handling manual and data validation plan
       CRF tracking and secure storage of CRF originals
       Application of established database systems (e.g. Oracle, MySQL)
       Data validation including plausibility checks
       Coding of diseases, concomitant medications AEs, SAEs, and active substances according to          standard nomenclature (ICD, INN, MedDRA™, ATC, WHODrug™, COSTART)
       Reconciliation of the data from the SAEs with data from Pharmacovigilance
       Compliance with the ICH-GCP Guidelines and other national and international standards and           regulations
       Database and data entry quality control prior to database lock

       Database close and exporting the data

Data Management