Clinical Data Management & Biostatistics

Bio­sta­tis­tics and Clin­i­cal Data Man­age­ment at ICRC-Wey­er are work­ing close­ly togeth­er in a flat report­ing struc­ture. As CDISC Gold Mem­ber we inten­sive­ly sup­port and ful­ly com­ply with the CDASH, SDTM and ADaM stan­dards. We devel­oped an adapt­able SAS-based Data Man­age­ment Sys­tem and are able to work in close con­nec­tion with numer­ous qual­i­fied EDC and DM sys­tems. Whether your study requires stan­dard sta­tis­ti­cal analy­ses or involves com­plex method­olog­i­cal issues, we are com­mit­ted to devel­op cus­tomized solu­tions which meet your research goals.

We have a ded­i­cat­ed team of bio­sta­tis­ti­cians who sup­ports you in devel­op­ment, val­i­da­tion and pro­gram­ming of analy­ses for a vari­ety of study designs and sta­tis­ti­cal approach­es. Our com­pa­ny cov­ers the fol­low­ing stan­dard tasks:

Biostatistics

  • Sta­tis­ti­cal sup­port regard­ing study design and CSP/CIP writ­ing at study start

  • Sam­ple size esti­ma­tion and randomization

  • Interim/Statistical analy­sis plan and mock writing

  • Sta­tis­ti­cal analy­sis for phase I–IV clin­i­cal, med­ical device stud­ies and numer­ous dif­fer­ent designs

  • Data review and pro­to­col devi­a­tion assessment

  • Inter­im analy­sis and meta-analysis

  • Phar­ma­co­ki­net­ic and phar­ma­co­dy­nam­ic analysis
  • Final study analysis
  • Report prepa­ra­tion and review
  • Data analy­sis in DiGA projects

Clinical Data Management

  • Elec­tron­ic Data Cap­ture (EDC, web-base data cap­ture), set­up, test­ing and maintenance
  • Case Report Form (CRF) Design and Print­ing, and/or eCRF

  • CRF Anno­ta­tions and Data­base Specifications

  • Data­base Design

  • Cre­ation of Data Man­age­ment Plans and Edit Check Specifications

  • PK and SAE Reconciliation

  • Data Val­i­da­tion and Query Management

  • Sys­tem for data cap­ture (SAS-based, paper or fax-transmitted)

  • Query sys­tem (EDC and SAS-based, han­dling of auto­mat­ed and man­u­al queries)

Coding

  • Devel­op­ment of tri­al-spe­cif­ic rou­tines and training

  • Code-dri­ven data validation

  • Review and val­i­da­tion of lega­cy codes or codes pro­vid­ed by a third party

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