ClinStat GmbH

Clinstat's experienced professional programmers work closely with biostatisticians in the creation and validation of analysis data sets and data displays. The statistical programming team is committed to deliver customized, fully validated deliverables. Our Statistical Programmers bring high-level education, good experience, and technical knowledge. With high-level professionals leading our programming team and expertise throughout the department, our programming staff is equipped to completely support the requirements of any project.

Our clinical statistics programming team members participate in annual programming conferences and workshops. The team members attend also external SAS training courses and conferences.

For any phase of drug development, our statistical programmer offer comprehensive services
including:

• Data analysis specifications according to the Statistical Analysis Plan (SAP)
  
• Creation of derived datasets
  
  • According to the CDISC implementation rules as ADAM datasets
    
  • Validation of datasets in co-operation with statistics department
    
• Data analysis
  
  • Planned analyses including designing analysis data sets, statistics, and displays
    
  • Interim analysis for adaptive designs and data
    
  • Analysis for safety monitoring boards (DSMBs)
    
  • Exploratory analyses for presentations, publications, abstracts, and marketing
    
  • Non-clinical trial analysis from epidemiologic studies and pre-clinical studies
    
  • Analysis of cost-effectiveness of products or public health data or reimbursement procedures
    
• Generation of efficient data displays using Tables, Listings, Figures (TLF) shells
  
  • Adjustments to client's standards
    
  • Independent validation at different levels
    
• Presentation/support at the FDA or other regulatory agencies
  
• Statistical programming training
  
  • Comprehensive Good Programming rules implemented in our set of SOPs
    
  • Introduction to statistical programming
    
• Customized project services
  
  • Creation and validation of analysis database
    
  • Creation and validation of data warehouse
    
  • Creation of ISS/ISE analysis databases
    
  • Special project programming according to individual client needs
    
• SAS ODS functionality to generate enhanced and easily readable output

Health economics addresses issues related to limitations in the allocation of health and healthcare resources. Limitations implies, that payers had to make choices among multiple, different interventions to get the best way of available funding. In this context demonstrating value for money is different. Does your drug or device improve clinical outcomes enough to justify the funds spent, compared with alternative uses of the same money?

ClinStats health economics and outcomes research services help you to perform:

• Cost of illness studies
  
• Budget impact analysis
  
• Cost-effectiveness modeling
  
• Piggy back analysis
  
• Dossier preparation for Health Technology Assessment (HTA) submissions
  
• Epidemiological and outcomes research studies
  
• Systematic reviews and meta-analysis
  
• Large-database analysis
  
• Qol instrument development and use

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)

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

Medical writing and the preparation of research-relevant documents must meet regulatory and clinical requirements. We ensure this through diligent planning of studies, accurate reporting, a well-documented approval process as well as constant monitoring and review.
All facts must be depicted and presented in a precise, clear and comprehensive manner. With our know-how and comprehensive resources, our team will prepare all study-specific documents and presentations for you. You can either take advantage of individual services included in our range of services or our complete medical writing service. We will work closely with you, taking company and study-specific needs into account, and we will always keep you up-to-date.

We support you with the preparation of:

• All medical/scientific information from literature
  
• Test plans
  
• Documentation sheets (CRFs)
  
• Standard operating procedures (SOPs)
  
• Clinical study reports and amendments
  
• Expert reports
  
• Meta-analyses
  
• Safety reports
  
• Interim reports, final report writing
  
• Documents to be submitted to government agencies and ethics committees
  
• Clinical summaries and overviews for worldwide regulatory submissions (MAA, NDA, BLA in CTD and eCTD format)
  
• Briefing documents for regulatory agencies
  
• Responses to questions from regulatory authorities

Regulatory Affairs Services