Data Management

   
 

Efficient data management speeds the clinical trial process and ensures excellent data collection accuracy and consistency. We can meet all of your clinical data management needs.
 
Our tools are extensively customized to meet your specific needs –both for paper-based and Electronic Data Capture (EDC)  trials. Our systems, SOPs and staff will provide you with cost-effective, secure, regulatory-compliant and efficient data management services.
 

Services:

  • Selection of Appropriate Technology and Processes for your Study

  • Case Report Forms (CRF)

  • Design and database implementation

  • Electronic Data Capture (EDC)

  • ePro/eDiary systems

  • Data validation and clinical programming

  • Electronic Data Integration and Transfer

  • Data Management Plan and Data Validation Plan preparation

  • Dictionary Preferred-Term Coding using MedDRA® and WHODD

  • Data review

  • Data Management and systems Audit
     

 

Biostatistics

Statistical Analysis is crucial the success of any clinical trial. Which is why we always strive to provide you with quality services and solutions.
 
Our experienced team of biostatisticians provide trial design consultation, statistical methodology recommendations, programming expertise as well as the reporting accuracy necessary to deliver your trial efficiently and on time.
 

Services:

  • Study design

  • Randomization schedules

  • Sample size calculations

  • Statistical consultancy

  • Statistical analysis

  • Analysis, tables, figures and listings programming

  • Statistical reporting

  • Input into the integrated clinical/statistical reports

  • Writing and reviewing of medical articles
     

 

 
”Our systems, SOPs and staff will provide you with cost-effective, secure, regulatory-compliant and efficient data management services.”
 

IRW Consulting AB  •  Kungsgatan 64  •  Box 130 78  •  103 02 Stockholm  •  Telephone +46(0)8 791 66 40  •  Fax +46(0)8 758 90 56  • info@irwcro.com

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