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Biometrics

Our comprehensive services cover the full biometrics life cycle, from initial study design and protocol development to statistical analysis and clinical study reporting. We take complete responsibility for managing your biometrics needs, including input and continuous support into your risk-based monitoring (RBM) plan, eCRF design, data validation, statistical analysis and medical writing. As master users of Viedoc™, the cutting-edge electronic data capture (EDC) system, we’ll provide effortless eCRF set-up and create highly sophisticated functions optimised for your study. In addition, we provide biostatistical and medical writing input to Data and Safety Monitoring Boards (DSMBs).

 

Excellence in Biometrics

Our advisory team is always on hand to provide guidance for optimisation of your study design, in order to meet your objectives and ensure delivery of high quality data.

Our biometrics services include:

  • Study design – enhanced by our strategic advisory tea
    Protocol writing – supported by our cross-disciplinary and broadly experienced medical writing team
  • eCRF set-up – development of an advanced but user friendly eCRF with smart built-in edit checks for real time data cleaning
  • Project management – executed by a dedicated project manager and Viedoc master-user who takes responsibility for all biometrics activities, from start to finish
  • Data management – data validation through advanced centralised monitoring including SAS-programmed checks as well as standard and customised reports, medical coding and clean file/database lock procedures
  • DSMB support – DSMB management and provision of study data for efficient data evaluation
  • CDISC standards – study data packaged into CDISC-compliant standards (SDTM/ADaM) and/or sponsor-specific standards
  • Biostatistics – knowledgeable and customer-focused support for randomisation, statistical analyses and statistical reporting, ensuring correct data interpretation and clear conclusions

    Medical writing – proficient writing and quality control of clinical study reports, safety summaries and publications
Updated
Jo Anders Rønneberg, PhD
Director Biometrics & Medical device
Norway
Tel:+ 47 95 08 28 06
jo@linkmedical.no    
Christopher Komujuni                        Associate Director EDC Management LINK Medical Sweden AB         
 
Mobile: +46(0)735 12 44 46
christopher.komujuni@linkmedical.se