Our Data Management Department provide an integrated data management service for regulatory clinical and medical device trials, academic and observational studies across a wide range of clinical specialities in hospital and community settings. 

This means seamless clinical data capture, validation, discrepancy management, storage, and archiving powered by the latest clinical research management technology. We can work on single site small scale studies through to multinational multi-centre clinical trials. We are committed to providing high quality data throughout the data management cycle. 

High quality data management services ensures integrity of data that conforms to ICH Good Clinical Practice guidelines, Medical Device guidelines, CRFG Standard Operating Procedures and any other regulatory requirements pertaining to a study. Data Management is the key to a successful project and therefore we integrate with the research team (CI, Sponsor, biostatistician, pharmacovigilance) from an early stage of the project through to completion.

Data Management Services include:

  • Protocol review 

  • Design Case Report Forms and write CRF Guidelines 

  • eCRF  development 

  • Data Management File set up and maintenance 

  • Data requirement specifications and Data validations documentation 

  • Data Management Plan development 

  • Clinical database creation and programming of validations/edit checks 

  • Clinical database testing prior to release 

  • Database training 

  • Database account management 

  • Study specific training with accompanying guidelines 

  • Case Report Form tracking for paper based studies 

  • MedDRA Coding of Adverse Events 

  • SAE reconciliation between the clinical and safety databases 

  • Import of electronic data sources into CDMS 

  • Data cleaning and query resolution  and quality processes (query creation, quality checks) 

  • Development and distribution  of status reports 

  • Database lock and Archive 

Our dynamic team currently comprises staff from a wide range of industry, academic, technical and clinical backgrounds:

  • Senior Clinical Data Manager 

  • Clinical Data Managers 

  • Database Developers 

  • Clinical Research Data Coordinators 

  • Masters students (on rotation) 

If you would like to find out more or to obtain a quote for data management services, please email biometrics@nuigalway.ie and we will contact you to discuss options. If you have accessed this page in order to download iDatafax 2016, please click for the Windows download OR here for iOS (MAC) download.