Harrison Clinical Research GmbH

Harrison Clinical Research
Albrechtstrasse 14
80636 Munich, Germany
Tel: 49-(0)89 - 12 66 80-0
Fax 49-(0)89 - 12 66 80-2444
Homepage: www.harrisonclinical.com

Data Management and Statistics

More than 15 years experience

Whether you require immediate assistance with a specific task, or professional advice and help with an entire project our commitment to quality and customer service is guaranteed.

From protocol to final study report - we can manage your clinical trial


Our Data management group offers more than 15 years experience in a broad range of therapeutic areas and services including:

  • Randomisation procedures including central Webbased randomisation and drug accountability services
  • CRF design according to HCR or sponsor templates
  • Preparation of data management plans
  • Database (e-CRF) design according to HCR or sponsor SOPs and systems
  • CRF and data query tracking through an electronic database system
  • Data entry and verification
  • Computerised edit checks for missing, implausible or inconsistent data in CRFs
  • Serious Adverse Event reconciliation
  • Medical coding with coding dictionaries such as Med-DRA®, ICD-9-CM, WHO DD
  • Preparation of CDISC Submission Data Modelling (SDTM) data

The data management group uses the following systems:

  • Microsoft Access 2000 database server application (FDA 21 CFR Part 11 compliant) with Double data entry and full audit trail capability for paper based studies
  • Using Marvin, from XClinical, a fully CDISC operational data model (ODM) compliant system, for EDC studies
  • Partnerships with e-diary vendors (CRF, Invivodata)
  • Sample size calculations using Nquery® software
  • Database transferal to client database, as required, e.g. as SAS datasets, preparation of CDISC submission data model (SDTM) compliant data
  • Standard pharmacokinetic analysis using WinNonLin© or Kinetica™ software
  • Special scanning and OCR software (Cardiff Teleform©) to retrieve data from observational studies, patient diaries or other questionnaires, if applicable.


Error rates for clinical databases are controlled and do not exceed 0.5% ( 5 errors per 1000 data fields) as an industry-wide standard. For critical data even zero errors based on a 100% review of data are obtainable. This is controlled and documented by database audits against CRFs.

HCR is an associate member of CDISC. CDISC (Clinical data interchange standards consortium, www.cdisc.org) is an open,multidisciplinary, non-profit organisation committed to the development of worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development.

Our Biostatistics group offers:

  • Advice on statistical aspects of study design and sample size issues
  • Statistical analysis plans
  • SAS programming
  • Special programming of non-standard statistical methods (e.g. published in latest articles)
  • Non-compartment pharmacokinetic analysis
  • Production of tables, figures and listings
  • Powerful statistical reports also as an independent service from external databases
  • Participation or Provision of Data in Data Monitoring Committees (DMCs) and Data Safety Monitoring Boards (DSMBs)


All statistical analysis is done with SAS® software. For special statistical tests, Cytel’s StatXact software is used. This set of special tests is completely integrated into SAS.

Our primary aims are accuracy, clarity, consistency and quality. We recognise the importance of effective communication in the achievement of your research objectives.